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Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

NCT06530823 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-07-31

No results posted yet for this study

Summary

This study is a single-arm, multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer.

The study anticipates enrolling 38 participants characterized by the following criteria: 1) A confirmed diagnosis of advanced, metastatic, or unresectable biliary tract cancer by histopathological examination; 2) Presence of FGFR2 fusion or rearrangement confirmed by testing; 3) Prior receipt of first-line treatment for biliary tract cancer.

The primary questions the study aims to address are:

1. Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer (BTC)?
2. What is the safety profile of the treatment with pemigatinib and durvalumab?

Participants will receive:

1. Oral administration of 13.5 mg pemigatinib once daily, in combination with durvalumab 1500 mg via intravenous infusion.
2. Follow-up visits will be scheduled every 6 weeks.

Investigators will observe and document the objective tumor response rate of the participants, as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and adverse events.

Conditions

Interventions

DRUG

Pemigatinib and Durvalumab

Pemigatinib combined with Durvalumab Pemigatinib: 13.5mg, oral administration, once daily, swallow the entire tablet with or without food. Take for 2 weeks and then discontinue for 1 week. Durvalumab: 1500mg, intravenous infusion, once every three weeks. Each infusion should take over 60 minutes.

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-08-01
Completion
2028-08-01

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Entities

Diseases

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 NCT06530823 on ClinicalTrials.gov