New drug cocktail aims to stop bile duct cancer from returning after surgery
NCT ID NCT04669496
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether giving a combination of an immunotherapy drug (toripalimab), a targeted therapy (lenvatinib), and chemotherapy (GEMOX) before surgery can improve outcomes for people with a high-risk type of bile duct cancer. The trial includes 178 patients whose cancer is removable but has features that make it likely to come back. The goal is to see if this pre-surgery treatment can delay or prevent recurrence and extend survival compared to surgery alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (PD-1 antibody), lenvatinib, and GEMOX chemotherapy
- What this could lead to
- If successful, this combination given before surgery could lower the chance of bile duct cancer coming back and improve long-term survival for high-risk patients.
- What could go wrong
- This is an early-to-mid stage trial with only 178 participants, so results may not apply to everyone. The drug combo can cause significant side effects, and it's not yet proven to be better than standard surgery alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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178 people
The number who actually took part.
- Started
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Jan 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\) Sign written informed consent 2) Male or female patients aged 18-70; 3) ECOG score 0 points, Child-Pugh rating A; 4) Pathological diagnosis by biopsy: Intrahepatic cholangiocarcinoma (ICC). 5) Resectable ICC patients with high risk factors for recurrence (tumor diameter\>5cm or imaging vascular invasion, multiple tumor nodules or hilar lymph node metastasis or Preoperative CA19-9 \>37 U/mL or above the upper limit of normal (for centers where the normal range is not \<37 U/mL); 6) The functional indicators of important organs meet the following requirements 1. Neutrophils≥1.5\*109/L; platelets≥90\*109/L; hemoglobin≥9g/dl; serum albumin≥3.5g/dl; 2. Coagulation function: International standardization (prothrombin time) ratio (INR) \<1.2; 3. T3 and T4 do not exceed the normal upper and lower limits by 2 times; 4. Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; 5. Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥ 60ml/min; 7) The subject has at least 1 measurable liver disease (according to RECIST1.1); 8) For women who are not breastfeeding or pregnant, use contraception during treatment or 3 months after the end of treatment. Exclusion Criteria: * 1\) Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-biliary cell carcinoma malignant tumor components; 2) Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening; 3) Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 4) Active tuberculosis infection. Patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, no formal anti-tuberculosis treatment or tuberculosis is still active; 5) Suffer from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases without systemic therapy can be selected; 6) Past interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy; 7) Long-term use of systemic hormones (dose equivalent to \>10mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids can be selected; 8) Active infections that require systemic treatment; 9) Human immunodeficiency virus (HIV, HIV1/2 antibody) positive; 10) A history of psychotropic drug abuse, alcohol or drug abuse; 11) Significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment; 12) Suspected of being allergic to study drugs; 13) Suffer from hypertension, and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 14) After antiviral therapy, HBvDNA\>104 copies/ml, HCV RNA\>1000; 15) Accompanied by ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis, etc. Combined with insufficiency of other organs, it is expected that they cannot accept general anesthesia or hepatectomy; 16) Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Zhongshan hospital
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can sound waves supercharge immunotherapy against bile duct cancer?
- Can blood tests reveal how liver and bile duct cancers respond to treatment?