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New cocktail of drugs shows promise for bile duct cancer

NCT ID NCT06465563

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug combination for people with advanced biliary tract cancer (bile duct cancer) who haven't had treatment before. About 93 participants will receive either a standard chemotherapy plus two immunotherapy drugs, or the same plus an extra experimental drug. The goal is to see if the new combo shrinks tumors better than the standard approach.

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

93 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Age 18\~75 years old, both male and female; 2. Histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma); 3. Has not received prior systemic anti-tumor therapy; 4. At least one measurable lesion based on RECIST v1.1 criteria; 5. ECOG PS score: 0-1 points; 6. Expected survival period ≥ 3 months; 7. Adequate organ function; 8. Must take one medically approved contraceptive measure; 9. Patients voluntarily joined the study and signed informed consent. Exclusion Criteria: 1. history or concurrently has other solid tumor; 2. Patients with liver tumor burden greater than 50% of total liver volume; 3. History of previous hepatic encephalopathy; 4. Patients with biliary obstruction ， at risk of biliary tract infection; 5. Patients with undergone major surgical treatment within 4 weeks before randomization; 6. Patients with any active, known or suspected autoimmune disorder; 7. Patients with active pulmonary tuberculosis; 8. Patients with known history of HIV or active hepatitis; 9. Untreated central nervous system metastasis; 10. Pleural or peritoneal effusion with clinical symptoms; 11. Patients with poorly controlled cardiac clinical symptoms or disease; 12. Patients with abnormal coagulation function and bleeding tendency; 13. Known allergic reaction to Adalimumab or other monoclonal antibodies, or to the trial drug; 14. Patients with other potential factors that may affect the study results.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma of gallbladder and extrahepatic biliary tract biliary tract cancer Biliary Tract Neoplasms extrahepatic bile duct carcinoma gallbladder cancer intrahepatic cholangiocarcinoma

As listed by the trial registrant

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

Biliary tract cancer

Contacts and locations

Locations

  • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

    Nanjing, Jiangsu, 210029, China

  • The First Affiliated Hospital，Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

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