Spots Global Cancer Trial Database for SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma

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Trial Identification

Brief Title: SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma

Official Title: 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

Study ID: NCT06199882

Conditions

Biliary Tract Carcinoma

Interventions

SBRT Sequential Surufatinib Combined With Immunotherapy

Study Description

Brief 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.