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

NCT07603349 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-08-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603349 on ClinicalTrials.gov