Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Conditions
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.
Interventions
DRUGCadonilimab
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
DRUGSOX chemotherapy
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
DRUGPlacebo
Placebo
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTZhifang Yao, MD
CONTACTJiafu Ji, MD
Outcome results
None listed