A Phase 2 interventional study of Toripalimab and Axitinib in Metastatic Clear Cell Renal Cell Carcinoma and Advanced Clear Cell Renal Cell Carcinoma, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
This prospective, open-label, single-arm Phase 2 study is evaluating toripalimab plus axitinib as induction therapy for adults with newly diagnosed metastatic clear cell renal cell carcinoma whose primary kidney tumor remains in place and whose baseline kidney-tumor core biopsy contains a biopsy-detectable tertiary lymphoid structure (TLS). TLS are organized immune-cell structures that may reflect an active anti-tumor immune environment.
Participants will receive approximately 12 weeks of toripalimab 240 mg by intravenous infusion every 3 weeks together with axitinib 5 mg by mouth twice daily. At Week 12, an independent multidisciplinary team will review treatment response, performance status, surgical risk, primary-tumor burden, metastatic burden, and the participant's preference to determine whether deferred cytoreductive nephrectomy is clinically appropriate. Surgery is not mandatory, and participants who do not undergo surgery will remain in the study's clinical follow-up cohort.
For participants who undergo deferred cytoreductive nephrectomy and still have at least one measurable metastatic lesion that has not been locally treated, the main clinical outcome is the proportion who are alive and free from disease progression 24 weeks after surgery. The study will also investigate whether the functional state of TLS in the treated primary kidney tumor and the persistence of TLS-associated T-cell and B-cell clones in blood after surgery are associated with longer control of remaining metastatic disease. Translational analyses may include pathology, multiplex immunofluorescence, T-cell and B-cell receptor sequencing, single-cell or single-nucleus sequencing, spatial transcriptomics, and serial blood sampling.
TACTIC-RCC is an investigator-initiated, prospective, open-label, single-center, single-arm Phase 2 clinical and translational study in treatment-naive patients with synchronous metastatic renal cell carcinoma containing a clear-cell component, an intact primary renal tumor, at least one measurable extracorporeal metastatic lesion by RECIST v1.1, and biopsy-detectable tertiary lymphoid structures (bdTLS) in the primary tumor.
All formally enrolled participants receive induction treatment with toripalimab 240 mg intravenously every 3 weeks plus axitinib 5 mg orally twice daily for approximately 12 weeks (four planned toripalimab cycles). Imaging is mandatory at Weeks 6 and 12. In addition to conventional RECIST v1.1 assessment, the study maintains lesion-level measurements that separate the primary renal tumor from individual metastatic lesions.
At Week 12, a multidisciplinary team that is independent of the translational results determines whether selective deferred cytoreductive nephrectomy (DCN) is clinically appropriate. The decision considers systemic treatment benefit, IMDC risk, performance status, anesthetic and surgical risk, primary-tumor burden, metastatic burden, technical resectability, the potential harm of systemic-treatment interruption, and participant preference. DCN is not mandatory and must not be performed solely to obtain research tissue. Participants who do not undergo surgery remain in the intention-to-treat clinical cohort and continue systemic management and follow-up according to clinical need.
For participants undergoing DCN, the last preoperative imaging assessment, preferably within 14 days before surgery, serves as the reference for residual metastatic disease. A postoperative confirmation scan is obtained approximately 4-6 weeks after surgery. Imaging is then performed every 8 weeks during the first 24 postoperative weeks and every 12 weeks thereafter. The surgery date is the landmark for postoperative time-to-event outcomes.
In participants without progression or unacceptable toxicity, toripalimab plus axitinib is generally resumed after adequate postoperative recovery. Toripalimab may continue for approximately 2 years in total, while axitinib may continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. For non-surgical participants, systemic therapy is continued or changed according to the same clinical principles.
The primary clinical endpoint is the 24-week progression-free survival rate from DCN (DCN-PFS) in the postoperative residual-metastasis primary analysis set. The primary translational endpoint is the association between a participant-level TLS Functional State Score (TLS-FSS), derived from post-treatment primary-tumor pathology and multiregional immune features, and 24-week DCN-PFS. A key mechanistic analysis evaluates a TLS-to-blood Clonal Persistence Index (TLS-CPI), which quantifies persistence of spatially localized TLS-associated T-cell or B-cell receptor clonotypes in serial blood after nephrectomy.
The translational program uses a tissue-to-blood-to-outcome framework. Baseline core biopsy establishes TLS eligibility. When available, nephrectomy tissue undergoes panoramic and multiregional pathology, multiplex immunofluorescence, TCR/BCR profiling, single-cell or single-nucleus transcriptomics, and spatial profiling. Serial peripheral blood mononuclear cells and plasma/serum are collected before and during induction, on the day of surgery, and after surgery to track immune clonotypes and systemic immune states.
The study is designed to estimate clinical and biomarker effect sizes rather than to prove that nephrectomy improves survival or that the primary renal tumor is required to maintain systemic anti-tumor immunity. Because surgery is selected after treatment according to clinical benefit and MDT judgment, analyses comparing surgical and non-surgical participants are descriptive or sensitivity analyses and are not intended as causal comparisons.
70 studies on the registry are indexed under Clear-cell metastatic renal cell carcinoma; 31 are open to participants now.
This study's planned enrollment of 30 is below the median of 39 across 63 interventional studies indexed under Clear-cell metastatic renal cell carcinoma.
Browse Clear-cell metastatic renal cell carcinoma studies →Fudan University is the lead sponsor of 1,317 studies on the registry; 645 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.
Exclusion Criteria:
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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 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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive toripalimab plus axitinib induction for approximately 12 weeks. At Week 12, an independent multidisciplinary team determines whether deferred cytoreductive nephrectomy is clinically indicated and safe. Surgery is selective rather than mandatory. Participants who do not undergo surgery continue systemic treatment or switch treatment according to clinical need and remain in study follow-up.
Drug: Toripalimab · Drug: Axitinib · Procedure: Deferred Cytoreductive Nephrectomy
Toripalimab 240 mg by intravenous infusion on Day 1 every 3 weeks, with four planned cycles during the approximately 12-week induction period. Dose reduction is not permitted. Treatment may be withheld or permanently discontinued for immune-related or other unacceptable toxicity. For participants without progression or unacceptable toxicity, toripalimab is generally resumed after adequate postoperative recovery (typically 2-6 weeks after surgery) or continued in non-surgical participants, for a total treatment duration of approximately 2 years.
Axitinib 5 mg orally twice daily, administered continuously during induction. Routine dose escalation is not planned. For intolerance, axitinib may be interrupted and reduced stepwise to 3 mg twice daily and then 2 mg twice daily. For elective surgery, axitinib is stopped at least 2 days before surgery, with 3-5 days preferred depending on bleeding/thrombotic and surgical considerations, and is not restarted until at least 2 weeks after major surgery and adequate wound healing. After recovery, axitinib may continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Selective cytoreductive nephrectomy considered after approximately 12 weeks of induction therapy. Core conditions include clear clinical benefit or controlled systemic disease, ECOG 0-1, acceptable anesthetic/perioperative risk, technically resectable primary tumor, a meaningful clinical purpose for surgery, and informed participant preference after MDT discussion. Surgical approach (radical or partial nephrectomy; open, laparoscopic, or robotic; management of venous tumor thrombus and lymph nodes when indicated) is determined by the surgical MDT.
Progression-Free Survival Rate From Deferred Cytoreductive Nephrectomy （24 months DCN-PFS rate）
The proportion of participants in the postoperative residual-metastasis primary analysis set who are alive and have not experienced centrally confirmed disease progression by RECIST v1.1 after deferred cytoreductive nephrectomy. In the primary strategy, initiation of a new systemic therapy or local treatment because of progression or symptoms from residual metastatic disease is counted as an event. iRECIST is used as a supportive assessment.
Time frame: From the date of deferred cytoreductive nephrectomy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months after surgery.
Association Between TLS-to-Blood Clonal Persistence Index (TLS-CPI) and 24-Week DCN-PFS
TLS-CPI is calculated from prespecified dominant TLS-associated clonotypes identified in the surgical specimen and their detection in postoperative blood. The primary TLS-CPI counts weighted clonotypes detected at at least two of postoperative Day 28, Week 12, and Week 24. Its association with 24-week DCN-PFS will be estimated using the prespecified regression framework.
Time frame: From the date of surgery through 24 weeks after surgery; blood samples include postoperative Day 28, Week 12, and Week 24.
Best Shrinkage Rate of Residual Metastatic Tumor Burden Within 24 Weeks After Surgery
For measurable metastatic lesions that remain untreated locally after nephrectomy, best shrinkage rate is calculated as: (preoperative reference metastatic burden - lowest metastatic burden within 24 postoperative weeks) / preoperative reference metastatic burden × 100%. The preoperative reference is the last suitable imaging assessment, preferably within 14 days before surgery.
Time frame: From the last preoperative reference scan through 24 weeks after deferred cytoreductive nephrectomy.
Incidence of Mixed Metastatic Response/Progression After Surgery
Descriptive incidence of heterogeneous lesion-level response after surgery, including patterns in which at least one metastatic lesion shows marked shrinkage while another lesion shows marked growth or a new lesion appears, according to the protocol-defined lesion-level framework.
Time frame: Assessed on postoperative imaging through at least 24 weeks after deferred cytoreductive nephrectomy.
Rate of MDT Recommendation for Deferred Cytoreductive Nephrectomy
Proportion of formally enrolled participants for whom the Week 12 multidisciplinary team recommends planned deferred cytoreductive nephrectomy.
Time frame: At the Week 12 multidisciplinary assessment.
12-month DCN-PFS rate
DCN-PFS is defined as the time from the date of deferred cytoreductive nephrectomy to the first radiographically documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last adequate tumor assessment. This outcome will be analyzed among participants who undergo deferred cytoreductive nephrectomy.
Time frame: From the date of deferred cytoreductive nephrectomy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months after surgery.
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Toripalimab · Axitinib
Clear-cell metastatic renal cell carcinoma →