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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pemigatinib and Durvalumab
DrugPemigatinib 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.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Pemigatinib and DurvalumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
Objective response rate is defined as the proportion of subjects who achieved a complete response (CR; disappearance of all target lesions) or a PR (\> 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1. Clinical response will be determined by an independent radiological review committee.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Progression-free Survival (PFS)
PFS=first dose to progression disease \[PD\] or death
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months2
Disease Control Rate (DCR)
DCR=CR+PR+satble disease
Time frame
From enrollment to the end of treatment at 8 weeks3
Overall survival (OS)
OS=first dose to death of any cause
Time frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months4
Adverse Event (AE)
Time frame
From enrollment to the end of treatment at 8 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: