NCT07023315

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for phase_3

Timeline
63mo left

Started Aug 2025

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Aug 2025Jul 2031

First Submitted

Initial submission to the registry

June 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 14, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

June 10, 2025

Last Update Submit

February 9, 2026

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Event-free survival (EFS)

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

    Up to 5 years

  • Pathological Complete Response (pathCR) Rate

    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.

    Up to approximately 2 years

Secondary Outcomes (3)

  • Overall survival (OS)

    Up to 10 years

  • Disease-free Survival (DFS)

    Up to 5 years

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

    Up to 5 years

Study Arms (2)

cadonilimab+SOX

EXPERIMENTAL

Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)

Drug: CadonilimabDrug: SOX chemotherapy

Placebo+SOX

PLACEBO COMPARATOR

Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)

Drug: SOX chemotherapyDrug: Placebo

Interventions

CadonilimabDRUG

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

cadonilimab+SOX
SOX chemotherapyDRUG

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

Placebo+SOXcadonilimab+SOX
PlaceboDRUG

Placebo

Placebo+SOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100143, 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

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Zhifang Yao, MD

CONTACT

86-0760-89873999clinicaltrials@akesobio.com

Jiafu Ji, MD

CONTACT

jijiafu@hsc.pku.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 16, 2025

Study Start

August 14, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2031

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

CN(6)