drugset / Trial / NCT07178340

Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach

NCT07178340 ↗

Phase 2 Recruiting 30 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if treatment modality including albumin-bound paclitaxel, oxaliplatin, tegafur,gimeracil and oteracil porassium capsules (SOX) and sintilimab works to treat locally advanced HER2-negative hepatoid adenocarcinoma of stomach. It will also learn about the safety of this modality. The main aim it aims to achieve are: * To evaluate the perioperative efficacy of albumin-bound paclitaxel combined with sintilimab and SOX in the treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach * To evaluate the safety and long-term benefits of albumin-bound paclitaxel combined with sintilimab and SOX regimens in perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of stomach Participants will: * Preoperative treatment with abumin-bound paclitaxel, SOX and sintilimab for 4 cycles * Radical surgery after 4-6 weeks of the preoperative treatment * Adjuvant treatment with albumin-bound paclitaxel, tegafur,gimeracil and oteracil porassium capsules and sintilimab for 4 cycles

Timeline

Start
2025-09-18
Primary completion
2027-09-20
Completion
2028-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject tegafur,gimeracil and oteracil porassium Unknown 40 mg Oral
Subject tegafur,gimeracil and oteracil porassium Unknown 50 mg Oral
Subject tegafur,gimeracil and oteracil porassium Unknown 60 mg Oral