Clinical trial NCT07023315: A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-06-16
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: Up to 5 years
measure: Pathological Complete Response (pathCR) Rate
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 10 years
measure: Disease-free Survival (DFS)
timeFrame: Up to 5 years
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Provincial Tumor Hospital
state: Tianjin
Study officials:
References: