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New drug cocktail shows promise for tough bile duct cancer

NCT ID NCT07619937

Disease control Sponsor: The First Affiliated Hospital of Zhengzhou University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tested a three-drug combination—chemotherapy infused into the liver, an immunotherapy drug (tislelizumab), and a targeted pill (regorafenib)—as a first treatment for 31 people with advanced bile duct cancer that couldn't be removed by surgery. The goal was to see how many patients' tumors shrank and how long they lived without the cancer growing. Researchers also tracked side effects. The study is complete, but results are not yet published.

What this could mean

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

Active substance
hepatic arterial infusion chemotherapy, tislelizumab, and regorafenib
What this could lead to
If this combination works, it could offer a new first-line treatment option for people with advanced bile duct cancer, potentially shrinking tumors and extending life.
What could go wrong
This is a small, single-center, single-arm phase II trial with only 31 participants, so results may not apply broadly. The combination also carries risks of side effects from chemotherapy, immunotherapy, and targeted drugs.

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

31 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 2025

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. Age 18-75 years ; 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic intra- or extrahepatic cholangiocarcinoma ; 3. Clinical stage III-IV according to the 8th edition of the AJCC TNM classification ; 4. No prior antitumor therapy; 5. Child-Pugh liver function class A or B ; 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 7. At least one measurable lesion per RECIST 1.1 ; 8. Adequate haematologic and hepatic/renal function; 9. Total bilirubin ≤ 2× upper limit of normal (patients who have undergone biliary drainage are eligible) ; 10. Adequate cardiac and pulmonary reserves to tolerate interventional procedures ; 11. Signed informed consent, good compliance, and ability to attend follow-up visits. Exclusion Criteria: 1. Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ; 2. Prior antitumor treatment ; 3. Concurrent primary malignancies; 4. Child-Pugh class C; 5. Severe cardiac, pulmonary, or renal dysfunction ; 6. Active autoimmune disease or need for long-term immunosuppressive therapy ; 7. Hypersensitivity to contrast agents or study drugs ; 8. Pregnancy or lactation; 9. Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

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

Cholangiocarcinoma

Contacts and locations

Locations

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

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