NCT06062485

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ampullary Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib+Toripalimab+AG	This is a single-arm, prospective, exploratory clinical study of unresectable or relapsing metastatic ampullary tumors who were not systematically treated with surufatinib in combination with PD-1 antibody and AG regimen.Until the investigator assesses loss of clinical benefit, unacceptable toxicity, decision by the investigator or subject to withdraw treatment, or death, whichever comes first.The AG regimen does not exceed 8 cycles, and maintenance therapy with surufatinib combined with toripalimab can be continued if the patient has not progressed after 8 cycles. The treatment period was 21 days; Tumor treatment and survival status were recorded until disease progression (RECIST 1.1) or death (during patient treatment). Surufatinib (200mg，qd，Q3W）；Toripalimab(240mg IV d1, Q3W)；AG（Albumin-bound paclitaxel: 125mg/m2，IV，d1，d8，Q3W）Gemcitabine: 1000 mg/m2, IV，d1，d8，Q3W）

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2023-10-02
• Last updated: 2023-10-02