A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cadonilimab
DrugAnti-PD-1/ CTLA-4 tetrameric bispecific antibody
SOX chemotherapy
DrugA combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
Placebo
DrugPlacebo
Treatment groups
760 Participants
are divided into 2 treatment groupsGroup A: cadonilimab+SOXExperimental treatment 2 interventions
Group B: Placebo+SOXPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Event-free survival (EFS)
EFS is the time from date of randomization until the date of disease progression or death.
Time frame
Up to 5 years2
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.
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Overall survival (OS)
Overall survival is length of time from randomization until the date of death due to any cause.
Time frame
Up to 10 years2
Disease-free Survival (DFS)
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.
Time frame
Up to 5 years3
Number of Participants Who Experience One or More Adverse Events (AEs)
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.
Time frame
Up to 5 years Source ClinicalTrials.gov