NCT06199882

SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma

A Single-arm, Open, Single-center Phase II Clinical Study on the Efficacy and Safety of SBRT Sequential Surufatinib Combined With Immunotherapy for Locally Unresectable or Recurrent Biliary Tract Cancer After First Surgery

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open, single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgery.

Detailed description

This is a single-arm, open, single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgery.The study was divided into three stages: screening period, treatment period and follow-up period. During treatment, imaging methods were used to evaluate tumor status every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during treatment) or toxicity became intolerable, and tumor treatment and survival status after disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	SBRT Sequential Surufatinib Combined With Immunotherapy	1. SBRT : Bioequivalent total dose \> 75Gy, completed within 2 weeks (once daily, 5 times a week). 2. Drug treatment (every 3 weeks is a treatment cycle) : 1\) Surufatinib: 200 mg, po, qd, taken continuously; 2) Carrelizumab: 200 mg/ time, intravenous drip on the first day of each cycle.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2024-01-10
• Last updated: 2024-10-15

Locations

1 site across 1 country: China