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

A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

This tests whether adding cadonilimab to SOX chemotherapy before and after surgery helps people with resectable stomach or gastroesophageal junction adenocarcinoma.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: cadonilimab, chemotherapy
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT07023315 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically confirmed, resectable gastric or GEJ adenocarcinoma (clinical stage T3‑4aN+M0 or T4bNanyM0), ECOG performance status 0–1, adequate organ function, an available tumor sample, and planned radical surgery are ideal candidates.

Not a fit: Patients with unresectable or metastatic disease, non‑adenocarcinoma histologies, prior anti‑cancer therapy for the current malignancy, active infections, or contraindications to the study drugs are unlikely to benefit.

Why it matters

Potential benefit: If successful, adding cadonilimab could reduce recurrence and improve cure rates for resectable gastric or gastroesophageal junction adenocarcinoma.

How similar studies have performed: Other trials combining immune checkpoint inhibitors with chemotherapy have shown benefit in some gastric/GEJ cancers, but perioperative use of cadonilimab specifically remains under investigation.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 5 other locations

• 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

Conditions Gastric and Gastroesophageal Junction Adenocarcinoma