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
Qualifiers
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
Treatments tested in this trial
- Cadonilimab
- SOX chemotherapy
- Placebo
Treatment groups
760 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov