Efficacy and Safety of Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma

NCT06062485 Phase 2 NOT_YET_RECRUITING

A Phase Ⅱ, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With recurrent or metastatic ampulla tumors.

Details

Lead sponsor	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	30
Start date	2023-10
Completion	2026-10

Conditions

• Ampullary Carcinoma

Interventions

• Surufatinib+Toripalimab+AG

Primary outcomes

• Objective response rate (ORR) — 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