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Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

NCT06949033 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2025-07-10

No results posted yet for this study

Summary

This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are:

1. Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery?
2. To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen.

Participants will be divided into two groups:

1. Experimental group: Participants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area).
2. Control group: Participants will receive a placebo in combination with the SOX regimen.

After completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.

Conditions

  • Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])
  • Neoadjuvant Therapy
  • Adjuvant Chemotherapy
  • pCR Rate
  • MPR
  • ORR,OS,PFS

Interventions

DRUG

Neoadjuvant cadonilimab combined with perioperative SOX

Cadonilimab: 10 mg/kg, iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA \< 1.25 m², 40 mg \* 2/day, 1.25 m² ≤ BSA \< 1.5 m², 50 mg \* 2/day, BSA ≥ 1.5 m², 60 mg \* 2/day)

DRUG

Neoadjuvant placebo plus perioperative SOX

Placebo: iv, day 1 of every 3 weeks Oxaliplatin: 130 mg/m², iv, day 1 of every 3 weeks S1: 40-60 mg/m², po, day 1-14 of every 3 weeks (BSA \< 1.25 m², 40 mg \* 2/day, 1.25 m² ≤ BSA \< 1.5 m², 50 mg \* 2/day, BSA ≥ 1.5 m², 60 mg \* 2/day)

Sponsors & Collaborators

  • Zuoyi Jiao

    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
2025-05-15
Primary Completion
2028-12-31
Completion
2030-12-31

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 NCT06949033 on ClinicalTrials.gov