Ivosidenib plus lenvatinib or PD‑1/PD‑L1 therapy for IDH1‑mutant advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open‑label, non‑randomized phase II umbrella trial using next‑generation sequencing to identify patients with IDH1‑mutant advanced biliary tract cancers. Eligible patients have measurable disease by RECIST 1.1, ECOG 0–1, and prior systemic chemotherapy failure; patients are assigned to receive ivosidenib combined with either a multi‑target tyrosine kinase inhibitor (represented by lenvatinib) or a PD‑1/PD‑L1 inhibitor. The study will follow participants for tumor responses, progression‑free survival, overall survival signals, and treatment‑related adverse events. Treatment effects and safety will be reported for each combination arm to explore whether adding targeted or immune therapy to ivosidenib improves outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Voluntary Participation: Signed informed consent.
* Genetic Mutation: Presence of an IDH1 mutation confirmed by genetic testing.
* Disease Status：
* Newly diagnosed, untreated advanced/metastatic disease; OR
* Recurrence \>6 months after curative-intent surgery (with or without adjuvant therapy).
* Measurable Disease: At least one measurable lesion per RECIST 1.1.
* Performance Status: ECOG performance status of 0 or 1.
* Life Expectancy： ≥3 months.
* Organ Function: Adequate hematological, hepatic, and renal function.
* Contraception: Use of highly effective contraception for women of childbearing potential and men.

Exclusion Criteria

* Prior Treatment: Previous treatment with Ivosidenib.
* Cancer Type: Ampulla of Vater cancer.
* Pregnancy： Pregnant or breastfeeding women.
* Allergy: Known hypersensitivity to any component of the study drugs.
* Recent Therapy: Local anti-tumor therapy or major surgery within 4 weeks prior to initiation.
* Medical Conditions:
* Uncontrolled hypertension.
* Significant cardiovascular disease.
* Active or untreated CNS metastases.
* Active autoimmune disease.
* Uncontrolled active infection (e.g., HBV, HCV, HIV).
* Significant bleeding tendency or history.
* Severe non-healing wounds.
* History of organ transplantation.
* Concurrent Participation: Participation in another interventional clinical trial.

Where it's running

• Beijing Peking Union Medical College Hospital Outpatient Department
  Beijing, China Recruiting

Study contacts

• Study coordinator: Chengjie Li
• Email: 1624271942@qq.com
• Phone: 13733879582

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.