Promising combo therapy shows hope for Hard-to-Treat bile duct cancer

NCT ID NCT07466238

Disease control Sponsor: Peking University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a treatment strategy for biliary tract cancer, a group of aggressive cancers with poor survival. The approach combines hepatic arterial infusion chemotherapy (HAIC) with systemic drugs like bevacizumab and an immunotherapy. The goal is to shrink tumors and improve survival, possibly allowing some patients to have surgery. The trial enrolls 40 patients who have not received prior treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: gemcitabine, oxaliplatin, 5-fluorouracil, bevacizumab, PD-1/PD-L1 inhibitor
What this could lead to: If successful, this approach could offer a more effective first-line treatment for advanced biliary tract cancer, potentially shrinking tumors enough to allow surgery and extend survival.
What could go wrong: This is a small, early-phase study with no control group, so results may not be generalizable. The combination therapy also carries risks of side effects from chemotherapy and immunotherapy.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

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

Started

Mar 2026

Expected to finish

Mar 2029

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 80 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: * Age: 18-80 years, both genders. * Diagnosis of biliary tract cancer (including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, and gallbladder cancer) and confirmed by histopathological or cytopathological examination. * Without distant metastasis or limited distant metastasis * Treatment-naive. * ECOG PS score \< 2. * Child-Pugh score: Class A or B (≤7). * Normal major organ function, meeting the following standards:(1) Blood routine examination:A. Hb≥90 g/L;B. ANC≥1.5×10\^9/L;C. PLT≥75×10\^9/L;(2) Biochemical examination:A. ALB ≥30g/L;B. ALT and AST\<5×ULN;C. TBiL ≤5×ULN;D. Creatinine ≤1.5×ULN;(3) Coagulation function:A. International normalized ratio (INR) ≤1.5×ULN;B. Activated partial thromboplastin time (APTT) ≤1.5×ULN. Exclusion Criteria: * Coexistent or synchronous malignancies. * Distal cholangiocarcinoma. * Allergic to contrast agents or oxaliplatin. * Pregnant or lactating women. * Multiple extrahepatic metastases or combined malignant pleural and peritoneal effusions. * History of organ transplantation. * With infections requiring anti-infection treatment. * Severe and irreparable coagulation dysfunction.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms gallbladder cancer intrahepatic cholangiocarcinoma perihilar intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer (BTC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Promising combo therapy shows hope for Hard-to-Treat bile duct cancer

What the study statuses mean