A Phase 2 interventional study of Toripalimab and Ipilimumab in Advanced RCC, sponsored by Jinling Hospital, China. Recruiting at 2 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Jinling Hospital, China · Phase 2, Interventional, and Treatment
The combination of immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKIs) has significantly improved clinical outcomes in patients with advanced renal cell carcinoma (RCC). However, 40%-60% of patients still develop primary or acquired resistance. For those with resistant disease, current immune rechallenge strategies have yet to demonstrate clear clinical benefit. Emerging evidence indicates that the gut microbiota plays a critical role in modulating responses to immunotherapy. Microbiota-modulating approaches, including fecal microbiota transplantation (FMT) and live bacterial formulations such as CBM588, have shown preliminary potential to enhance sensitivity to immunotherapy and improve patient outcomes. Nevertheless, whether gut microbiota modulation can resensitize advanced RCC to immunotherapy remains to be investigated.
The REMEDY-RCC trial is an investigator-initiated, prospective, open-label, phase II, parallel two-cohort exploratory study primarily designed to investigate whether gut microbiota modulation can restore sensitivity to immunotherapy in patients with advanced RCC. Given the substantial differences in the tumor immune microenvironment and response to ICIs between clear cell RCC (ccRCC) and non-clear cell RCC (nccRCC), this study employs a parallel two-cohort design to stratify these two patient populations: a primary cohort consisting of patients with metastatic ccRCC, and an exploratory cohort consisting of patients with metastatic nccRCC. The primary and secondary endpoints will be analyzed in the primary cohort, whereas the exploratory cohort will be used solely for exploratory and descriptive analyses. The study plans to enroll approximately 33 adult patients with advanced or metastatic RCC, including 27 with metastatic ccRCC and 6 with metastatic nccRCC. Eligible patients will receive the following sequential interventions: bowel decontamination with amoxicillin-clavulanate potassium followed by polyethylene glycol (PEG) solution, high-dose gut colonization and maintenance supplementation with live Clostridium butyricum powder combined with soluble dietary fiber, and immune rechallenge therapy consisting of a PD-1 immune checkpoint inhibitor (ICI) combined with four cycles of a CTLA-4 ICI, followed by maintenance therapy with the PD-1 ICI alone. Treatment will continue until disease progression, unacceptable toxicity, completion of the planned treatment cycles, or withdrawal of consent.
The REMEDY-RCC trial requires specific follow-up for enrolled patients. Radiological response is assessed longitudinally using computed tomography (CT). Tissue and body fluid samples collected from patients will be used for biomarker and multi-omic analyses.
The primary endpoint of the trial is the objective response rate (ORR) in the primary cohort, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Sample size for the primary cohort was determined using Simon's optimal two-stage design, with a one-sided α of 0.10 and power (1-β) of 0.80. The unacceptable response rate (P0) was set at 17.4%, based on the ORR observed in the FRACTION-RCC study for nivolumab plus ipilimumab rechallenge in patients with metastatic ccRCC who had progressed after prior immunotherapy. The target response rate (P1) was established considering that FMT has been shown to increase ORR by approximately 20% in immunotherapy-resistant melanoma. Given that metastatic RCC and melanoma are both considered immunologically responsive tumor types, a comparable therapeutic benefit from gut microbiota remodeling is anticipated. Accordingly, P1 was set at 37.4%. This effect size is clinically meaningful and would be non-inferior to the clinical efficacy of cabozantinib in metastatic RCC that has progressed following immunotherapy.
The primary cohort will initially enroll six patients for safety assessment. If the treatment is deemed safe, further accrual will follow Simon's two-stage design, and enrollment of the exploratory cohort will be considered. After these six patients, an additional six patients will be enrolled, bringing the total to 12, at which point an interim analysis will be performed. If the number of objective responses at the interim analysis is ≤ 2, the trial will be terminated early. If ≥3 objective responses are observed, an additional 12 patients will be enrolled, resulting in a total sample size of 24 patients. Accounting for a potential 10% dropout rate, the study plans to enroll 27 patients in total.
The exploratory cohort is planned to enroll no more than 6 patients (not exceeding 20% of the total enrollment), with a fixed-sample descriptive design. The sample size calculation is not based on statistical hypothesis testing, and all efficacy endpoints will be reported using descriptive statistics. The total planned sample size is 33 patients, comprising 27 patients in the primary cohort and 6 patients in the exploratory cohort.
Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Based on the pathological subtype, enrolled patients will be assigned to two cohorts: the primary cohort consists of patients with histologically confirmed metastatic clear cell RCC, and the exploratory cohort consists of those with histologically confirmed metastatic non-clear cell RCC (subtypes limited to papillary, chromophobe, or unclassified).
Exclusion Criteria:
- Recent Microbiota Interference Patients are excluded if they have received systemic antibiotics within 4 weeks prior to screening, or have received any live bacterial preparations or commercial prebiotics within 2 weeks prior to screening, or are currently using or plan to use probiotics, yogurt, or foods supplemented with bacteria during the treatment period.
- Immune-Related Severe Toxicity or Status
Patients are excluded if they meet any of the following criteria:
Have a history of permanent discontinuation of immunotherapy due to immune-mediated adverse events;
Have active or known autoimmune disease, except for type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and vitiligo;
Have an status, defined as confirmed immunodeficiency, receipt of systemic at a dose equivalent to >10 mg of prednisone per day or other immunosuppressive agents (excluding inhaled or topical corticosteroids), or a history of active autoimmune disease requiring systemic therapy within the past 2 years.
- Prior Specific Immunotherapy or Excessive Therapy Patients are excluded if they have received prior treatment with a ICI or more than two prior systemic therapy regimens.
- Gastrointestinal Risk Factors Patients are excluded if they have a history of inflammatory bowel disease (including Crohn's disease or ulcerative colitis); chronic severe diarrhea; or grade ≥3 immune-related colitis; or present with gastrointestinal lesions; or have undergone major abdominal surgery that may impair intestinal absorption or peristaltic function.
- Oral Administration Barrier Patients are excluded if they have dysphagia or are unable to take the required oral study medication.
- Rapid Tumor Progression Patients are excluded if they have rapidly progressive disease such that, in the opinion of the investigator, they cannot safely tolerate a 4-week and a 2-week reconditioning period.
- Active Interstitial Lung Disease or Pneumonitis Patients with active interstitial lung disease or pneumonitis, or a history of either condition requiring systemic steroid therapy, are excluded.
- Uncontrolled or Central Nervous System Disease Patients with known brain metastases, cranial epidural disease, or significant vasogenic edema are excluded unless they have received adequate radiotherapy or surgery and have been stable for at least 4 weeks prior to the first dose of study treatment.
- Severe Cardiac Disease Patients are excluded if they have a history of myocarditis or congestive heart failure ( [NYHA] class III-IV), unstable angina, uncontrolled severe arrhythmia, or myocardial infarction within 6 months prior to enrollment.
- Recent Other Antineoplastic Treatment Patients are excluded if they have received, prior to the first dose of study treatment:any small molecule kinase inhibitor within 2 weeks; cytotoxic agents, biologics, or other systemic anticancer therapies within 4 weeks; radiotherapy for bone metastases within 2 weeks, or any other radiotherapy within 4 weeks.
Patients are excluded if they meet any of the following criteria:
White blood cell count \<2.0 × 10⁹/L, \<1.5 × 10⁹/L, or count \<100 × 10⁹/L;
/ALT >3 × , or >5 × ULN in patients with liver metastases, or total >1.5 × ULN (except for Gilbert's syndrome); ③ \<30 mL/min or serum creatinine >1.5 × ULN.
Patients are excluded if they have any of the following:
Uncontrolled tumor-related pain, with painful lesions requiring palliative radiotherapy to be managed prior to enrollment;
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage more frequently than once per month, the presence of an indwelling catheter such as a PleurX® device is permitted; ③Moderate to severe hepatic impairment, defined as class B or C; ④Uncontrolled or symptomatic hypercalcemia.
Patients are excluded if they meet any of the following criteria:
Have received prior stem cell transplantation or solid organ transplantation;
Have active (HBV DNA positive), active (HCV RNA positive), or infection;
Have undergone major surgery within 4 weeks prior to study treatment;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible patients first received oral amoxicillin-clavulanate potassium (914mg, BID) for 5 days, followed by a 1-day washout. On day 7, PEG solution (74g, single dose PO) was administered for intestinal decontamination. From day 8 onward, a high-dose regimen of live Clostridium butyricum powder (120mg, BID PO) combined with soluble dietary fiber (5g, BID PO) was given orally for seven days to promote gut colonization. Beginning on day 15, patients received four cycles of toripalimab (240 mg, Q3W) plus ipilimumab (1mg/kg, Q3W) intravenously. During this combination immunotherapy period, subjects continued to take oral live Clostridium butyricum powder (80mg, BID PO) and soluble dietary fiber (10g, BID PO) until the initiation of the fifth immunotherapy cycle. From the fifth cycle onward, patients switched to toripalimab monotherapy (240mg, Q3W) until disease progression, unacceptable toxicity, completion of the prespecified treatment course, or withdrawal from the study.
Drug: Toripalimab · Drug: Ipilimumab
Beginning on day 15, patients receive toripalimab (240 mg, Q3W IV) until disease progression, unacceptable toxicity, completion of the prespecified treatment course, or withdrawal from the study. Dose modifications are as follows: administration of toripalimab may be delayed in patients suspected of experiencing grade 3 or higher adverse events attributable to toripalimab, as per CTCAE version 5.0. In the event of serious adverse reactions, treatment discontinuation is permitted. Investigators may adjust the dosing regimen for patients achieving a complete or partial response, in accordance with the study protocol.
Also known as: anti-PD-1 monoclonal antibody
Patients will receive four cycles of ipilimumab (1mg/kg, Q3W IV). During study treatment, if a patient experiences Grade ≥2 or intolerable adverse events, the investigator may evaluate the patient's condition and resume toripalimab plus ipilimumab therapy after the toxicity has resolved to Grade ≤1 or returned to baseline, with a treatment interruption not exceeding 21 days in principle. Ipilimumab should be discontinued, and the patient should enter the study follow-up phase, if any of the following criteria are met:①Grade ≥3 immune-related adverse events,② symptomatic progression leading both the physician and patient to opt for an alternative treatment, ③patient refusal to continue ipilimumab therapy, or the investigator's judgment that ipilimumab is no longer appropriate for the patient.
Also known as: anti-CTLA-4 monoclonal antibody
Objective Response Rate(ORR)
The efficacy population (EP) comprised patients who received at least one dose of toripalimab plus ipilimumab and had measurable disease at baseline. Tumor responses were assessed by an independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The best overall response was defined as either complete response (CR) or partial response (PR). The primary endpoint was the proportion of patients in the EP achieving CR or PR. All responses required confirmation by repeat imaging performed at least four weeks after the initial documentation.
Time frame: Up to 2 years after treatment
Progression-Free Survival（PFS）
PFS was defined as the time from the first treatment date to the first documented disease progression per RECIST version 1.1 as assessed by an IRC, or death from any cause, whichever occurred first. For patients who had not experienced an event by the analysis data cutoff date, data were censored at the date of the last radiological evaluation.
Time frame: Up to 2 years after treatment
Disease Control Rate（DCR）
Per RECIST version 1.1, the proportion of patients in the EP with a best overall response of CR, PR, or stable disease (SD) was assessed by an IRC. Confirmed responses (CR/PR) required repeat imaging at least 4 weeks after the initial documentation. SD had to be maintained for at least 8 weeks from the first assessment.
Time frame: Up to 2 years after treatment
Duration of Response（DoR）
Among patients achieving a CR or PR, the DOR was defined as the time from the first documented response (CR or PR) to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
Time frame: Up to 2 years after treatment
Overall Survival（OS）
OS was defined as the time from the first treatment date to death from any cause. Patients who were still alive or lost to follow-up at the analysis data cutoff date were censored at the date of the last known alive status.
Time frame: Up to 2 years after treatment
Safety and Tolerability
Safety and tolerability were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The safety analysis set (SAS) comprised all patients who received at least one dose of toripalimab plus ipilimumab. Evaluated parameters included the incidence, severity, and causal relationship to the treatment regimen of treatment-related adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), as well as the proportion of patients with treatment discontinuation, dose delay, or dose adjustment due to adverse events.
Time frame: Up to 2 years after treatment
Patient quality of life - Assessment will be performed using the NCCN FKSI-19+.
The NCCN FKSI-19⁺ is a disease-specific symptom burden scale for patients with renal cell carcinoma. It comprises 19 core items that capture disease-related symptoms, treatment side effects, and functional status, making it suitable for longitudinal clinical monitoring and efficacy evaluation. The assessment time points include: baseline (before treatment), week 6 (with an allowable window of ±7 days), week 12 (with an allowable window of ±7 days), and every 12 weeks thereafter (±7 days) until the end of treatment.
Time frame: Up to 2 years after treatment
Patient quality of life - Assessment will be performed using the QLQ-C30.
The EORTC QLQ-C30 is a core quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer. It comprises 30 items that assess five functional domains (physical, role, cognitive, emotional, and social), three symptom domains (fatigue, nausea/vomiting, and pain), global health status, and several single-item symptom measures. It is widely used for the standardized assessment of health-related quality of life in patients with malignant tumors. The assessment time points include: baseline (before treatment), week 6 (with an allowable window of ±7 days), week 12 (with an allowable window of ±7 days), and every 12 weeks thereafter (±7 days) until the end of treatment.
Time frame: Up to 2 years after treatment
Patient quality of life - Assessment will be performed using the EuroQoL EQ-5D-5L.
The EuroQoL EQ-5D-5L is a preference-based generic health status instrument consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five severity levels, along with a visual analog scale. It is used to derive health utility values and is applicable for cost-utility analysis and population health surveys. The assessment time points include: baseline (before treatment), week 6 (with an allowable window of ±7 days), week 12 (with an allowable window of ±7 days), and every 12 weeks thereafter (±7 days) until the end of treatment.
Time frame: Up to 2 years after treatment
Patient quality of life - Assessment will be performed using the HADS.
The Hospital Anxiety and Depression Scale (HADS) comprises 14 items, with seven items each for the anxiety and depression subscales, scored on a four-point scale from 0 to 3. It was designed for use in non-psychiatric hospitalized patients to minimize the interference of somatic symptoms with the assessment of emotional states. The scale demonstrates good clinical feasibility, reliability, and validity. The assessment time points include: baseline (before treatment), week 6 (with an allowable window of ±7 days), week 12 (with an allowable window of ±7 days), and every 12 weeks thereafter (±7 days) until the end of treatment.
Time frame: Up to 2 years after treatment
Objective Response Rate in the Exploratory Cohort
Tumor responses were assessed by an Independent Review Committee according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In the exploratory cohort, among all patients who received at least one dose of toripalimab in combination with ipilimumab and had measurable disease at baseline, the objective response rate was defined as the proportion of patients whose best overall response was either complete response or partial response. All responses required confirmation by repeat imaging performed at least four weeks after the initial documentation. All summarized results for the above endpoints will be described using only descriptive statistics, and are intended to serve as hypothesis-generating evidence for future investigations.
Time frame: Up to 2 years after treatment
Progression-Free Survival in the Exploratory Cohort
Progression-free survival (PFS) was evaluated in the exploratory cohort. PFS was defined as the time from the start of first treatment to the first occurrence of either disease progression confirmed by an Independent Review Committee according to RECIST version 1.1, or death from any cause, whichever occurred first. For patients who had not experienced any of these events by the data cutoff date, their data were censored at the date of the last radiographic assessment. All summarized results for the above endpoints will be described using only descriptive statistics, and are intended to serve as hypothesis-generating evidence for future investigations.
Time frame: Up to 2 years after treatment
Analysis of Peripheral Blood Samples.
In this study, peripheral blood samples will be collected before, during, and after treatment. Flow cytometry and other techniques will be used to assess dynamic changes in the peripheral immune microenvironment and to explore potential circulating biomarkers.
Time frame: Up to 2 years after treatment
Analysis of Fecal Samples
In this study, fecal samples will be collected before, during, and after treatment. Metagenomic sequencing together with 16S rRNA gene sequencing will be performed to analyze alterations in gut microbiome diversity over the course of treatment.
Time frame: Up to 2 years after treatment
Analysis of Tumor Tissue Specimens
Tumor tissue specimens will be obtained before and after treatment to characterize changes in the tumor microenvironment.
Time frame: Up to 2 years after treatment
Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.
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Studies of the drug tested here: Toripalimab