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

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07603349
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Alternative Postoperative Treatment Regimen — DRUG
    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.
  • Original Treatment Regimen — DRUG
    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.
  • Postoperative Observation — OTHER
    Participants will undergo postoperative observation without further antitumor drug therapy. Routine follow-up monitoring will be conducted according to the study protocol.

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
405 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Experimental Arm
    Participants randomized to the cohort 1 experimental arm will switch to an alternative postoperative treatment regimen. The alternative regimen will be selected by the investigator based on the participant's preoperative treatment regimen, postoperative molecular subtype, and the 2025 CSCO and 2025 NCCN guidelines. The regimen should include taxane-based or irinotecan-based monotherapy or combination therapy that was not used before surgery. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information.
  • Active Comparator: Cohort 1 Control Arm
    Participants randomized to the Cohort 1 control arm will continue treatment according to the preoperative treatment regimen. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information.
  • Experimental: Cohort 2
    Participants in Cohort 2 will undergo postoperative observation without routine antitumor drug therapy. They will receive regular follow-up monitoring according to the study protocol.

Primary Outcome Measure

Median Event-Free Survival in Cohort 1（mEFS） [ Time Frame: Up to approximately 13 months ]

Central Contacts

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