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A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.
This is a single-arm, open-label, prospective clinical study aimed at observing and evaluating the efficacy and safety of surufatinib combined with immunotherapy and chemotherapy in the treatment of unresectable or metastatic biliary tract cancer.
Details
| Lead sponsor | Fujian Cancer Hospital |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 23 |
| Start date | 2025-01 |
| Completion | 2027-12 |
Conditions
- Biliary Tract Cancer
Interventions
- Surufatinib+Toripalimab+GEMOX
Primary outcomes
- Progression free survival (PFS) — from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1