Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma

Sponsor
National Cancer Center, Japan
Study ID
NCT07699939
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction (GEJ) Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • serplulimab — DRUG
    Patients receive perioperative treatment with S-1 plus oxaliplatin (SOX) in combination with Serplulimab.
  • Placebo — DRUG
    Patients receive perioperative treatment with S-1 plus oxaliplatin (SOX) in combination with placebo.

Study Details

To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 15, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Jun 30, 2029

Study Design

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

Arms

  • Experimental: SOX+HLX10
    Neoadjuvant treatment period: SOX+HLX10 Surgery Postoperative adjuvant treatment period: HLX10
  • Placebo Comparator: SOX+Placebo
    Neoadjuvant treatment period: SOX + Placebo Surgery Postoperative adjuvant treatment period: SOX

Primary Outcome Measure

Pathological complete response (pCR) rate by central pathology review [ Time Frame: Approximately 4-5 months after randomization (after surgery) ]

Central Contacts

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