Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEastern Hepatobiliary Surgery Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years, men and women;
ECOG performance status of 0-1;
Histologically confirmed advanced gallbladder cancer or cholangiocarcinoma patients who have received one prior line of therapy;
Adult patients with advanced, metastatic, or unresectable cholangiocarcinoma or gallbladder cancer confirmed to have FGFR2 fusion or rearrangement;
Disqualifiers
Patients who have not received standard first-line treatment for advanced biliary tract tumors;
Pregnant or breastfeeding women, and women of childbearing age with positive pregnancy test results at baseline;
Patients diagnosed with central nervous system metastasis by CT/MR/PET-CT;
Patients who have previously received live vaccine administration or other antitumor treatments such as radiotherapy;
Trial design
Treatments tested in this trial
- Pemigatinib and Durvalumab
Treatment groups
38 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov