Cadonilimab with SOX chemotherapy given before and after surgery for removable stomach or gastroesophageal junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial enrolls patients with resectable gastric or gastroesophageal junction adenocarcinoma who are fit for radical surgery (ECOG 0–1). Participants receive cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin plus tegafur‑gimeracil‑oteracil) given both before surgery (neoadjuvant) and after surgery (adjuvant). Tumor samples are collected prior to entry and all patients proceed to planned radical resection followed by postoperative therapy. The study compares safety and efficacy of perioperative cadonilimab plus chemotherapy versus perioperative chemotherapy alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
3. Has life expectancy of at least 6 months.
4. Availability of tumor sample prior to study entry.
5. Patients must undergo radical surgery.
6. Has adequate organ function.

Exclusion Criteria:

1. Patients with unresectable locally advanced disease or distant metastasis.
2. Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
3. Current or prior use of immunosuppressive medication within 14 days before randomization.
4. Has received prior anti-cancer therapy for the current malignancy.
5. Has an active infection requiring systemic therapy.
6. Contra-indication to any of the study drugs.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
8. Has an active autoimmune disease that has required systemic treatment in past 2 years.
9. Known active Hepatitis B or Hepatitis C virus infection.
10. Has had an allogenic tissue/solid organ transplant.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Provincial Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Tianjin Provincial Tumor Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Zhifang Yao, MD
• Email: clinicaltrials@akesobio.com
• Phone: 86-0760-89873999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• LM-302 plus oral S-1 and intraperitoneal paclitaxel, with or without cadonilimab, for Claudin 18.2–positive advanced stomach or GEJ cancer with peritoneal spread

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.