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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2026

Conditions
Ampullary Carcinoma
Interventions
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)"

All Listed Sponsors
lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

NCT06062485 - Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma | Biotech Hunter | Biotech Hunter