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NOT YET RECRUITING
NCT07603349
PHASE2/PHASE3

Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate postoperative adaptive adjuvant therapy in patients with gastric or gastroesophageal junction adenocarcinoma after neoadjuvant chemotherapy plus immunotherapy and radical gastrectomy.The main questions it aims to answer are: 1. In patients with poor pathological response, does switching to a alternative postoperative treatment regimen improve survival? 2. In patients with complete pathological response, can observation without routine postoperative treatment maintain favorable survival outcomes? Participants will be assigned to different cohorts according to their pathological response after surgery and will be followed regularly for recurrence, survival, and treatment-related side effects.

Official title: Efficacy and Safety of Postoperative Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Radical Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

405

Start Date

2026-06

Completion Date

2029-12

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Alternative Postoperative Treatment Regimen

Participants in this arm will switch to an alternative postoperative treatment regimen selected by the investigator according to prior neoadjuvant therapy, postoperative molecular subtype, and the 2025 CSCO and NCCN guidelines. The regimen will include taxane-based or irinotecan-based treatment that was not used before surgery, with dosage and administration based on clinical practice standards and drug prescribing information.

DRUG

Original Treatment Regimen

The original preoperative treatment regimen will be continued postoperatively. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information.

OTHER

Postoperative Observation

Participants will undergo postoperative observation without further antitumor drug therapy. Routine follow-up monitoring will be conducted according to the study protocol.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China