A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.

Not provided0 sites23 target enrollmentJanuary 2025

ConditionsBiliary Tract Cancer

InterventionsSurufatinib+Toripalimab+GEMOX

DrugsSurufatinib+Toripalimab+GEMOX

Overview

Phase: Phase 2
Intervention: Surufatinib+Toripalimab+GEMOX
Conditions: Biliary Tract Cancer
Sponsor: Not provided
Enrollment: 23
Primary Endpoint: Progression free survival (PFS)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

December 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Not provided

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have fully comprehended this study and voluntarily signed the Informed Consent Form;
•Age ≥ 18 years;
•Inoperable or metastatic biliary tract carcinoma confirmed by histopathology or cytology;
•Hepatic function classified as Child-Pugh Class A (scores 5-6) or Class B with favorable prognosis (score ≤7) (refer to Appendix 3);
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (refer to Appendix 1);
•Anticipated survival ≥ 12 weeks;
•At least one measurable lesion according to RECIST 1.1 criteria (refer to Appendix 2);
•Essentially normal function of major organs and bone marrow:
•Complete blood count: WBC ≥ 4.0 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L;
•Prothrombin time expressed as International Normalized Ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN;

Exclusion Criteria

•Patients who relapsed within 6 months after previous immunosuppressive therapy;
•Clinically symptomatic central nervous system metastases and/or carcinomatous meningitis;
•Biliary obstruction that, in the investigator's judgment, has not resolved or requires anti-infective treatment within 14 days prior to the first study drug administration despite clinical intervention;
•History of liver transplantation;
•Active autoimmune disease or immunodeficiency;
•Any surgery or invasive treatment or procedure (excluding venous catheterization, puncture drainage, etc.) within 4 weeks prior to study enrollment;
•Uncontrolled hypertension not managed with medication, defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg;
•Urinalysis indicating proteinuria ≥2+ and, with a 24-hour urine protein quantification \>1.0g;
•Current presence of any disease or condition affecting drug absorption, or the patient's inability to orally ingest sorafenib;
•Current active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases, or active bleeding from an unresected tumor, or other conditions deemed likely to cause gastrointestinal bleeding or perforation by the investigator;

Arms & Interventions

Experimental: Experimental

Intervention: Surufatinib+Toripalimab+GEMOX

Outcomes

Primary Outcomes

Progression free survival (PFS)

Time Frame: 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

Secondary Outcomes

Objective response rate (ORR)(from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year)
Overall survival (OS）(from randomization until death due to any cause, assessed up to 3 year)
Disease control rate (DCR）(from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year)
Safety and tolerance evaluated by incidence, severity and outcomes of AEs(from first dose to 30 days post the last dose)