Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient voluntarily joins this study and signs the informed consent form.
Age: ≥18 years, male or female.
Histologically or cytologically confirmed advanced biliary tract malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
No prior systemic therapy for advanced BTC (biliary tract cancer).
Disqualifiers
Has another active malignancy other than BTC within 5 years or concurrently.
Has poorly controlled cardiac clinical symptoms or diseases.
Has hypertension that cannot be reduced to normal range with antihypertensive medication; has a history of hypertensive crisis or hypertensive encephalopathy.
Any clinically significant gastrointestinal disorders, including bleeding, inflammation, obstruction, or diarrhea > grade 2.
Trial design
Design model
Parallel
Treatments tested in this trial
FGFR Inhibitor
DrugFGFR Inhibitor
IDH1 mutation inhibitor
DrugIDH1 mutation inhibitor
KRAS mutation inhibitor
DrugKRAS mutation inhibitor
NTRK mutation inhibitor
DrugNTRK mutation inhibitor
BRAF V600E mutation inhibitor
DrugBRAF V600E mutation inhibitor
BRCA 1/2 mutation inhibitor
DrugBRCA 1/2 mutation inhibitor
HER2 target therapy
DrugHER2 target therapy
Immune Checkpoint Inhibitors
DrugImmune Checkpoint Inhibitors
Chemotherapy: GP/GEMOX
DeviceChemotherapy: GP/GEMOX
Treatment groups
240 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions
Group C: Arm CExperimental treatment 2 interventions
Group D: Arm DExperimental treatment 2 interventions
Group E: Arm EExperimental treatment 2 interventions
Group F: Arm FExperimental treatment 2 interventions
Group G: Arm GExperimental treatment 2 interventions
Group H: Arm HExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of subjects in the analysis population who have a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.
Time frame
From enrollment to upto 2 yearsSecondary outcomes
1
Progression-Free Survival (PFS)
Progression-Free Survival (PFS), defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
Time frame
From enrollment to upto 2 years2
Overall Survival (OS)
Overall Survival (OS), defined as the time from randomization to death from any cause.
Time frame
From enrollment to upto 3 years3
Disease Control Rate (DCR)
Disease Control Rate (DCR), defined as the percentage of patients with confirmed complete response, partial response, or stable disease (≥ 8 weeks) among efficacy-evaluable patients.
Time frame
From enrollment to upto 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: