New hope for bile duct cancer: triple therapy shows promise after chemo fails

NCT ID NCT04834674

Disease control Sponsor: Sichuan Cancer Hospital and Research Institute Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested a combination of three treatments—local chemotherapy delivered via beads into the liver, a targeted drug called apatinib, and an immunotherapy (PD-1 antibody)—in 20 patients with advanced bile duct cancer that had worsened after standard first-line chemotherapy. The goal was to see if this approach could shrink tumors and delay progression. The study is completed, and results will show whether this combination is safe and effective enough to become a new second-line option.

What this could mean

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

Active substance: combination of drug-eluting beads transarterial chemoembolization (DEB-TACE), apatinib, and a PD-1 antibody
What this could lead to: If successful, this combination could offer a new second-line treatment option for patients with advanced bile duct cancer who have run out of standard options.
What could go wrong: This is a small Phase 2 trial with only 20 participants, so results may not apply to everyone. The combination therapy also carries risks like liver damage, bleeding, and immune-related side effects.

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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

20 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2026

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: 1. The diagnosis of ICC 2. Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria. 3. Stand first-line chemotherapy resistance. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. Child Pugh score ≤ 7. 6. Not amendable to surgical resection ,local ablative therapy and any other cured treatment. 7. Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 8. Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan Exclusion Criteria: 1. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 2. Known history of HIV 3. History of organ allograft 4. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 5. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 6. Evidence of bleeding diathesis. 7. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. 8. Known central nervous system tumors including metastatic brain disease 9. Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation. 10. Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration. 11. Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma intrahepatic cholangiocarcinoma

As listed by the trial registrant

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

Apatinib Intrahepatic cholangiocarcinoma PD-1 antibody Transarterial chemoembolization

New hope for bile duct cancer: triple therapy shows promise after chemo fails

What the study statuses mean