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Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma

NCT07786766 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-08-26

No results posted yet for this study

Summary

This is a prospective, single-arm, phase II clinical study. Patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have either not previously received standard therapy or have experienced treatment failure following standard therapy will be screened for eligibility and enrolled in the study after providing written informed consent.

Conditions

  • Biliary Tract Cancer (BTC)

Interventions

DRUG

Pemigatinb

Pemigatinib will be administered orally once daily in a self-administered manner. Each treatment cycle will consist of 21 days, including 14 consecutive days of treatment followed by a 7-day treatment-free period. The dose will be 13.5 mg once daily.

DRUG

PD-1 inhibitors

PD-1 inhibitors are not restricted to a specific agent. Commonly used agents include pembrolizumab and toripalimab. PD-1 inhibitors will be administered by intravenous infusion on Day 1 of each 21-day cycle (Q3W). The recommended doses are 200 mg for pembrolizumab and 240 mg for toripalimab. The dosage and administration of other PD-1 inhibitors will be based on the respective product labeling.

DRUG

Chemotherapy

The decision to administer combination chemotherapy will be made by the investigator based on a comprehensive assessment of the patient's performance status, organ function, and personal preferences. Combination chemotherapy is generally recommended as part of the standard treatment regimen; however, it may be omitted in patients who are unable to tolerate chemotherapy due to poor general condition or impaired organ function. If combination chemotherapy is administered, the chemotherapeutic agents will be given by intravenous infusion on Day 1 of each 21-day treatment cycle, with one cycle consisting of 3 weeks (Q3W). The most commonly used chemotherapy regimen is the GEMOX regimen.

Sponsors & Collaborators

  • Haitao Zhao, MD

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07786766 on ClinicalTrials.gov