A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma

Phase 3

Not yet recruiting

• Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
• Interventions: Drug: Cadonilimab; Drug: SOX chemotherapy

• Registration Number: NCT07023315
• Lead Sponsor: Akeso

Brief Summary

This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.

Detailed Description

This trial is a Phase 3 study. All patients are resectable gastric or gastroesophageal junction adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-16
• Last Update Posted: 2025-06-16
• Study Start: 2025-07
• Primary Completion: 2029-07
• Study Completion: 2031-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 760

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cadonilimab+SOX	Cadonilimab	Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
Placebo+SOX	SOX chemotherapy	Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
cadonilimab+SOX	SOX chemotherapy	Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	Up to 5 years	EFS is the time from date of randomization until the date of disease progression or death.
Pathological Complete Response (pathCR) Rate	Up to approximately 2 years	PathCR rate is defined as the percentage of participants having a pathCR assessed by the investigators.; PathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 10 years	Overall survival is length of time from randomization until the date of death due to any cause.
Disease-free Survival (DFS)	Up to 5 years	DFS is defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause.
Number of Participants Who Experience One or More Adverse Events (AEs)	Up to 5 years	An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Trial Locations

Locations (6)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Tianjin Provincial Tumor Hospital; 🇨🇳 Tianjin, Tianjin, China