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NOT YET RECRUITING
NCT07712094
PHASE2

AK112 Combination Therapy as First Line Treatment for Metastatic Digestive System Neuroendocrine Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer.

Official title: A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic Digestive System Neuroendocrine Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-08-01

Completion Date

2029-08-31

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

AK112

Combination treatment period (4-6 cycles): AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks Maintenance treatment period: AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks

DRUG

Irinotecan

Combination treatment period (4-6 cycles): Irinotecan: 65 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks

DRUG

Cisplatin

Combination treatment period (4-6 cycles): Cisplatin: 30 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks

PROCEDURE

TACE

Combination treatment period: TACE with epirubicin, 30-40 mg, every 3 weeks or every 6 weeks. The total treatment cycle is determined as needed.

Locations (8)

Baotou Cancer Hospital

Baotou, Inner Mongolia, China

The First People's Hospital of Horqin District, Tongliao City

Tongliao, Inner Mongolia, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Tianjin First Central Hospital

Tianjin, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Tianjin Medical University General Hospital

Tianjin, China

Tianjin People's Hospital

Tianjin, China

Tianjin Third Central Hospital

Tianjin, China