New cocktail of drugs shows promise against tough bile duct cancer
NCT ID NCT05451290
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of immunotherapy (camrelizumab), a targeted therapy (apatinib), and chemotherapy (gemcitabine and oxaliplatin) given before and after surgery for 30 people with advanced biliary tract cancer. The goal is to see if this approach can shrink tumors enough for successful removal and delay cancer return. Participants will also take a maintenance drug (tegafur) for up to a year after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab, apatinib, gemcitabine, oxaliplatin, and tegafur
- What this could lead to
- If successful, this combination could help shrink tumors before surgery and prevent recurrence afterward, potentially improving survival for people with advanced biliary tract cancer.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drug combination can cause serious side effects, and it's not yet proven to be better than standard treatments.
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
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- 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 75 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. Informed consent document must be signed. 2. Aged 18-75 years old, both genders. 3. Pathologically confirmed biliary tract adenocarcinoma and haven't been treated before. 4. An Eastern Cooperative Oncology Group performance status of 0 to 1. 5. Locally advanced biliary tract adenocarcinoma confirmed by MDT discussion. 6. The function of vital organs meets the following requirements: the blood ANC count≥1.5x109 /L; hemoglobin ≥ 90 g/L,the blood platelet count≥80 x109 /L, total bilirubin ≤ 1.5 x ULN, ALT and AST ≤3 x ULN(\< 5 x ULN for patients with live metastasis), serum creatinine≤1.5 x ULN, endogenous creatinine clearance rate ≥45ml/min. 7. At least 1 measurable lesion as defined by RECIST 1.1. 8. Women of reproductive age need to take effective contraceptive measures during and within 3 months of the end of medication. 9. Subjects should have good compliance and cooperate with the follow-up. Exclusion Criteria: 1. Subject has any active autoimmune disease or history of autoimmune disease will not be included, nor will patients with active tuberculosis or hepatitis or HIV. 2. Subjects with illness or medical conditions that could jeopardize their sugery, such as severe cardiopulmonary insufficiency and coagulation disorders, cannot be enrolled. 3. Subjects with active malignancies other than BTC within 5 years should be excluded, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and superficial bladder cancer \[Ta, Tis \& T1\] and papillary thyroid cancer. 4. Any unstable systemic disease which might need systemic treatment should not be enrolled (including active infection, liver or renal disease, metabolic disease, acute cerebral infarction or hemorrhage), or serious co-morbidities that by the judgment of the investigator, may compromise the patient's safety or impair the patient's ability to complete the study. 5. Subjects who have significant cardiovascular events should not be enrolled, for example: congestive heart failure \> NYHA class 2, unstable angina, active coronary artery disease (CAD) (only allow the subjects with presence of myocardial infarction more than 1 year prior to study); severe arrhythmias in need of treatment (only allow those been treated with β-blockers or digoxin) or uncontrolled hypertension. 6. Subjects with history of neurological or psychiatric disease, including epilepsy or dementia or diseases alike should not be enrolled. 7. Subjects with interstitial lung disease or a history of interstitial pneumonia should not be enrolled. 8. Subjects who had participated in other anti-tumor clinical trials within 4 weeks prior to enrollment should be avoided. 9. Subjects who had used PD-1/PD-L1 or other antitumor immunotherapeutic agents prior to enrollment should be avoided. 10. The following subjects should be avoided: pregnant or lactating women; those who have childbearing potential and unwilling or unable to use effective contraception measures. 11. Other circumstances that could affect the trial or the result of the study judged by the investigator.
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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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the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
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Other studies related to the condition(s) this trial covers.
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