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New cocktail of drugs shows promise against tough bile duct cancer

NCT ID NCT05451290

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.