Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

Sponsor
Eastern Hepatobiliary Surgery Hospital
Study ID
NCT06530823
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Biliary Tract Carcinoma
  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemigatinib and Durvalumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2024
Primary completion
Aug 1, 2026
Completion
Aug 1, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemigatinib and Durvalumab
    The combination of targeted drugs and immunotherapies has demonstrated their clinical value in the treatment of various tumors, and pemigatinib and durvalumab are such a promising combination product. In this combination, Pemigatinib is used according to the following rules: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 is used as this: 1500mg, intravenous infusion, once every three weeks. Each infusion should take over 60 minutes.

Primary Outcome Measure

Objective Response Rate [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

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