About this trial
The goal of this randomized, open-label, phase II clinical trial is to determine whether adding the PD-1/CTLA-4 bispecific antibody QL1706 to standard SOX chemotherapy increases the pathological complete response rate in adults aged 18-75 years with resectable, locally advanced, diffuse-type, HER2-negative gastric adenocarcinoma (cT3-4aNxM0). Participants will be randomly assigned (1:1) to receive 3-4 neoadjuvant cycles of QL1706 plus SOX or SOX alone every 3 weeks, followed by curative-intent gastrectomy with D2 lymphadenectomy, and will be monitored post-operatively every 3 months for 2 years and every 6 months thereafter for recurrence, survival, and safety.
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- QL1706 (Iparomlimab/Tuvonralimab)
- SOX Chemotherapy
Treatment groups
Sponsors and collaborators
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
First Affiliated Hospital of Suzhou Medical College
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
The Affiliated Jiangning Hospital of Nanjing Medical University
Collaborator