Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgery in Limited-metastatic G/GEJ Adenocarcinoma — ROSETTE  

Gastric Cancer Clinical Trial

Official title: Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgery in Patients With Limited-metastatic Gastric or Gastroesophageal Adenocarcinoma: an Open-label, Single-center, Phase 2 Trial (ROSETTE Trial)

Status Not yet recruiting

Clinical Trial Summary

The objective of this trial is to compare the efficacy of a comprehensive treatment strategy involving PD-1 monoclonal antibody combined with XELOX chemotherapy followed by radical resection surgery, versus simple systemic treatment in patients with limited distant metastasis of gastric adenocarcinoma/gastroesophageal junction adenocarcinoma.

After enrollment and successful screening, eligible participants will be randomized in a 1:1 ratio into a surgical arm and a non-surgical arm, and will undergo the following treatment:

Surgical Arm:

1. Phase 1 Systemic Therapy: Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4.

2. Surgery: Performing a D2 standard gastrectomy for gastric cancer and radical resection of resectable metastatic lesions.

3. Phase 2 Systemic Therapy: Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8, followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment.

4. During phase 2 systemic therapy, concurrent local treatments for unresected metastatic lesions are permitted, including radiotherapy, interventional embolization, radiofrequency ablation, and hyperthermic intraperitoneal chemotherapy (HIPEC).

Non-Surgical Arm:

1. Phase 1 Systemic Therapy: Administration of PD-1 monoclonal antibody in combination with XELOX chemotherapy for cycles 1-4.

2. Phase 2 Systemic Therapy: Continuation of PD-1 monoclonal antibody combined with XELOX chemotherapy for cycles 5-8, followed by maintenance therapy with PD-1 monoclonal antibody and capecitabine monotherapy from the 9th cycle until two years post-enrollment.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• GastroEsophageal Cancer

• NCT number: NCT06468280
• Study type: Interventional
• Source: Shanghai Zhongshan Hospital
• Contact: Xuefei Wang, MD, PhD
• Phone: 0
• Email: wang.xuefei@zs-hospital.sh.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Completion date: July 2028