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NCT Number: NCT07023315

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

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.

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Key information

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

cadonilimab

Drug

Anti-PD-1/ CTLA-4 tetrameric bispecific antibody

SOX Chemotherapy

Drug

A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium

Placebo

Drug

Placebo

Primary outcomes

  1. Event-free survival (EFS)

    Time frame: Up to 5 years

    EFS is the time from date of randomization until the date of disease progression or death.

  2. Pathological Complete Response (pathCR) Rate

    Time frame: 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 outcomes

  1. Overall survival (OS)

    Time frame: Up to 10 years

    Overall survival is length of time from randomization until the date of death due to any cause.

  2. Disease-free Survival (DFS)

    Time frame: 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.

  3. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiafu Ji, MD

CONTACT

[email protected]

Zhifang Yao, MD

CONTACT

[email protected]

86-0760-89873999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Jun 16, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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