A Phase 2 interventional study of hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab in Intrahepatic Cholangiocarcinoma, sponsored by Lianghe Lu. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Lianghe Lu · Phase 2, Interventional, and Treatment
Among 229 studies in Cholangiocarcinoma with a site in China — 113 open to participants now, 124 under way, 12 of them phase 3. Cholangiocarcinoma · China.
Among the 229 studies in Cholangiocarcinoma with a site in China, this one is the 129th largest by planned enrollment of the 190 interventional ones that give a count, is one of 21 that started in 2026, is one of 100 in phase 2, reaches primary completion later than 96 of the 123 other live ones, and was the 225th registered.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
Browse Cholangiocarcinoma studies →113 of the 229 studies in Cholangiocarcinoma with a site in China are open now. Recruiting first, the newest first:
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Virogin Biotech Ltd. · Sites in China
Peking University Third Hospital · Sites in China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Nanfang Hospital, Southern Medical University · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 211 Cholangiocarcinoma studies recruiting now, 141 (67%) set no upper age limit and 49 (23%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
229 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 29 · Phase 2 117 · Phase 3 25 · Phase 4 3
First in 2006; this study’s year is marked. 21 started in 2026.
This study's planned enrollment of 35 is below the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.
Median enrollment 51 across the 190 interventional studies, 150 across the 39 observational. Of the 51 that completed or were terminated, 7 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
40 of 229 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Lianghe Lu as lead sponsor.
Lianghe Lu has 1 study filed under Cholangiocarcinoma — fewer than ten, so there is no comparison to draw.
27 of the studies in Cholangiocarcinoma with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05823311Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityLenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma | 2026-12-31 |
| NCT05342194Phase 3Shanghai Junshi Bioscience Co., Ltd.Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study | 2027-05-31 |
| NCT05727176Taiho Oncology, Inc.Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement | 2026-12 |
| NCT07359586Zhejiang UniversityLaryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia | 2026-12-25 |
| NCT06664021Anhui Provincial HospitalExploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma | 2026-12-30 |
Among the 229 studies in Cholangiocarcinoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Intrahepatic cholangiocarcinoma (ICC) has an increasing global incidence, and over 70% of patients are diagnosed at unresectable stages with limited survival benefits from standard first-line chemotherapy regimens. Hepatic arterial infusion chemotherapy (HAIC) delivers high-concentration local chemotherapy to liver tumors, while the PD-1/CTLA-4 dual antibody iparomlimab and tuvonralimab (QL1706) combined with bevacizumab can reshape the immunosuppressive tumor microenvironment and exert synergistic anti-tumor effects.The purpose of this study is to evaluate the efficacy and safety of HAIC-FOLFOX plus QL1706 and bevacizumab as first-line therapy for patients with unresectable HER2-negative intrahepatic cholangiocarcinoma.
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.
1. Age ≥18 years and ≤75 years. 2. Good general condition with Performance Status (ECOG-PS) score of 0-1.
3. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma (ICC).
4. No prior anti-tumor treatment for intrahepatic cholangiocarcinoma. 5. Confirmed as unresectable, non-ablatable and not eligible for other curative-intent therapies after multidisciplinary discussion by the hepatobiliary tumor expert team of this hospital.
6. Laboratory test results meet the following criteria (or achievable after short-term medical intervention):
1. ≥ 2.0 × 10⁹/L 2. ≥ 100 g/L 3. count ≥ 75 × 10⁹/L 4. Plasma albumin ≥ 35 g/L 5. Total serum \< 2 × (ULN) 6. (ALT) \< 3 × ULN 7. Aspartate aminotransferase (AST) \< 3 × ULN 8. Serum creatinine \< 1.5 × ULN 9. is normal or no more than 4 seconds above the ULN 10. International normalized ratio (INR) ≤ 2.2 7. Subjects fully understand the study and provide written . 8. score ≤ 6 (Child-Pugh A class). 9. At least one per version 1.1 (RECIST v1.1).
10. For women of (including non-surgically sterilized subjects): use medically-accepted during study treatment and for 3 months after completion of study treatment; serum or urine human chorionic gonadotropin (HCG) test must be negative within 72 hours prior to enrolment; must not be lactating. For male subjects with female partners of child-bearing potential: effective contraception is required during the study and for 3 months after the last dose of iparomlimab-tuvonralimab.
11. Expected survival ≥ 12 weeks. 12. No history of diseases.
Exclusion Criteria:
1. Severe impairment of major organs including heart, brain, lung or kidney; severe infection or other serious comorbidities ( v5.0 adverse events ≥ Grade 2) rendering the subject intolerant to study treatment.
2. History of other malignant neoplasms. 3. History of allergic reactions to relevant study drugs. 4. Known to any component of iparomlimab-tuvonralimab or to other monoclonal antibody agents.
5. History of solid-organ transplantation. 6. Prior anti-tumor therapy (including interferon) for ICC. 7. (HIV) infection. 8. History of drug abuse or illicit-drug use. 9. Gastrointestinal hemorrhage or cardiovascular/cerebrovascular events within 30 days prior to enrolment.
10. Pregnant or lactating women; women of unwilling to adopt measures.
11. Psychiatric disorders that preclude or proper study participation.
12. , or bone requiring urgent surgical or radiotherapy intervention.
13. Active disease or relevant medical history (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Note: Subjects with vitiligo; subjects with childhood-onset asthma fully resolved without intervention in adulthood may be enrolled; subjects requiring bronchodilators for asthma are excluded.
14. Receiving agents or systemic for immunosuppressive purposes (prednisone > 10 mg/day or equivalent), and still on such therapy within 2 weeks before enrolment.
15. Administration of within 4 weeks prior to study drug initiation or planned live-vaccine administration during study participation.
16. Other conditions judged by the investigator to interfere with study conduct or subject safety, such as heavy alcohol consumption, substance abuse, severe comorbid illnesses, marked laboratory abnormalities, or family/social circumstances that may compromise subject safety or protocol compliance.
17. bleeding episodes or definite bleeding tendency within 3 months before enrolment, e.g. hemoptysis ≥ 2.5 mL, gastrointestinal bleeding, high-risk esophageal-gastric varices, bleeding peptic ulcer, vasculitis. Note: If baseline stool occult blood is positive, repeat testing is required. Persistently positive stool occult blood warrants gastroscopy; subjects with severe esophageal-gastric varices on gastroscopy are excluded. Subjects with gastroscopy performed within the prior 3 months to rule out varices are exempt from repeat gastroscopy.
18. Uncorrectable coagulopathy or marked hematologic abnormalities with clear bleeding tendency (e.g. hemophilia, coagulation disorders, severe thrombocytopenia).
19. -PS score ≥ 2. 20. score ≥ 7 (Child-Pugh B or C class). 21. Evidence of hepatic decompensation, e.g. massive ascites, history of upper gastrointestinal bleeding due to esophageal-gastric varices within the past year, hepatic encephalopathy or encephalopathy.
22. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
23. -positive tumor status. 24. Any other conditions that, in the investigator's opinion, may interfere with subject enrolment or endpoint assessment.
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.
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 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.
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).
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.
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.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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 score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
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.
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.
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.
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.
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 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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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.
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.
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.
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.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: hepatic arterial infusion chemotherapy (HAIC) combine with QL1706 and bevacizumab
Drug page: Iparomlimab/Tuvonralimab
Eligible patients were treated with HAIC plus QL1706 and bevacizumab. On the treatment day, continuous hepatic artery chemotherapy infusion was administered via an indwelling catheter connected to a micro-infusion pump. The infusion regimen included oxaliplatin 130 mg/m² over 3 hours, leucovorin 400 mg/m² over 1.5 hours, 5-FU 400 mg/m² over 2 hours, and 5-FU 2400 mg/m² over 46 hours. The catheter was removed after infusion completion. On the subsequent morning, patients received intravenous QL1706 (7.5 mg/kg) and bevacizumab (15 mg/kg), and were discharged after infusion. Treatment was repeated every 3-4 weeks for up to six cycles. Patients with favorable responses received continuous systemic maintenance therapy. Maintenance treatment was continued until death, intolerable toxicity, or loss of clinical benefit, with therapeutic regimens adjusted according to individual clinical status.
Also known as: HAIC, QL1706, Bevacizumab
objective response rate，ORR
ORR was defined as the proportion of patients achieving best overall response of complete response (CR) or partial response (PR) per RECIST 1.1.
Time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
disease control rate, DCR
DCR was defined as the proportion of patients achieving a best overall response of complete response (CR), partial response (PR), or stable disease.
Time frame: From first dose of study treatment until the earliest of progression, death, start of subsequent anti-tumor therapy, or data cutoff, assessed up to 24 months.
progression-free survival, PFS
PFS was defined as the time from randomization to first documented tumor progression per RECIST 1.1 or death from any cause, including death without prior disease progression. Patients without progression at data cutoff or lost to follow-up were censored at the date of last adequate tumor assessment.
Time frame: From date of randomization until the date of first documented progression or death, assessed up to 24 months.
Overall survival, OS
OS was defined as the time from first dose of study treatment to death from any cause. Patients who were alive at data cutoff or lost to follow-up were censored at the date last known to be alive.
Time frame: From date of first study treatment until death from any cause, assessed up to 36 months.
Safety evaluation
Treatment-related adverse events were assessed according to the CTCAE 5.0 criteria.
Time frame: From the date of first study treatment until 90 days after the last dose of study treatment.
Exploratory Biomarker Analysis
Exploratory biomarker analyses will assess the correlation between baseline and on-treatment biological molecular characteristics and clinical efficacy outcomes including ORR, PFS and OS. Tumor tissues and serial peripheral blood samples collected during the study will be utilized for exploratory multi-omics sequencing and immunological detection, including single-cell sequencing and other high-throughput sequencing analyses. Dynamic changes of intratumor microenvironment, immune characteristics and molecular profiles before and after treatment will be explored and correlated with clinical prognosis. All biomarker analyses are descriptive without formal hypothesis testing, aiming to screen potential predictive and pharmacodynamic biomarkers, explore possible treatment resistance mechanisms, and provide scientific basis for individualized treatment optimization.
Time frame: From screening up to 24 months after the first dose of study treatment.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
Of 147 non-industry phase 2 interventional studies under Cholangiocarcinoma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 65. This study's planned 24 months is below that.
Counting every sponsor, half of 173 studies reached it within 46 months; a quarter within 29 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Iparomlimab/Tuvonralimab