Starting soon
Phase 2
Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study
Condition(s) studied
Bile Duct CarcinomaCholangiocarcinoma
Investigational drug(s) / intervention(s)
FGFR InhibitorIDH1 mutation inhibitorKRAS mutation inhibitorNTRK mutation inhibitorBRAF V600E mutation inhibitorBRCA 1/2 mutation inhibitorHER2 target therapyImmune Checkpoint InhibitorsChemotherapy: GP/GEMOX
FGFR Inhibitor: FGFR Inhibitor
IDH1 mutation inhibitor: IDH1 mutation inhibitor
KRAS mutation inhibitor: KRAS mutation inhibitor
NTRK mutation inhibitor: NTRK mutation inhibitor
BRAF V600E mutation inhibitor: BRAF V600E mutation inhibitor
BRCA 1/2 mutation inhibitor: BRCA 1/2 mutation inhibitor
HER2 target therapy: HER2 target therapy
Immune Checkpoint Inhibitors: Immune Checkpoint Inhibitors
Chemotherapy: GP/GEMOX: Chemotherapy: GP/GEMOX
Study summary
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
Inclusion Criteria:
* 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).
* At least one measurable lesion as per RECIST v1.1 (spiral CT scan long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm; lesions previously treated with local therapy may be considered target lesions only after documented progression according to RECIST v1.1).
* ECOG performance status: 0-1.
* Expected survival ≥12 weeks.
* Adequate major organ function.
* Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before the first dose, must not be breastfeeding, and must voluntarily agree to use effective contraceptive measures during the study period and for 6 months after the last dose of chemotherapy. For male subjects with a female partner of childbearing potential, they must be surgically sterile or agree to use effective contraceptive measures during the study period and for 3 months after the last dose of chemotherapy; sperm donation is not allowed during the study.
* Subjects are expected to have good compliance and be able to follow the protocol requirements for efficacy and adverse event follow-up.
Exclusion Criteria:
* 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.
* Has experienced thrombotic or embolic events within 6 months before the start of study treatment.
* Use of strong CYP3A4/CYP2C19 inducers (including rifampin and its analogues, and St. John's Wort) or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent form.
* Has uncontrolled infection at screening.
* Patients with congenital or acquired immunodeficiency.
* Has a history of brain metastases or has brain metastases.
* Women who are pregnant or plan to become pregnant during the study treatment period.
* Other patients deemed unsuitable for inclusion by the treating physician.
Primary outcome measure(s)
- Objective Response Rate (ORR) — From enrollment to upto 2 years
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.
Trial sites (1)
| Facility | City | Region | Status |
| The First Affiliated Hospital of Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
|
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