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
Qualifiers
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
Treatments tested in this trial
- FGFR Inhibitor
- IDH1 mutation inhibitor
- KRAS mutation inhibitor
- NTRK mutation inhibitor
- BRAF V600E mutation inhibitor
- BRCA 1/2 mutation inhibitor
- HER2 target therapy
- Immune Checkpoint Inhibitors
- Chemotherapy: GP/GEMOX
Treatment groups
240 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov