This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma.
The research subjects were patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant/adjuvant therapy that occurred more than 6 months after disease progression/recurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.
The patient voluntarily participated, provided informed consent, signed a written informed consent form, and had good compliance.
Age ≥18 years (including), male and female. 3)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4）Expected survival period ≥3 months.
Previously received any drug or cell therapy targeting CLDN18.2
Received major surgery, live vaccine administration, or Drug therapy with other investigational medicinal products, or received radiotherapy within 2 weeks prior to randomization.
Imaging shows cerebral tumor lesions (unless whole-brain radiotherapy or surgery, etc., local treatment has been completed, and imaging and clinical stability have been assessed according to the protocol) 4)Peripheral neuropathy ≥ Grade 2
Parallel
Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine
DrugJS107: 2 mg/kg on day 1 Q3W; Toripalimab (T): 240 mg on day 1 Q3W. Capecitabine (C): 750 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 100mg/m² on Day1 Q3W, Maximum of 6 cycles.
Sintilimab& Oxaliplatin Injection& Capecitabine
DrugSintilimab: 3 mg/kg or 200 mg Day1 Q3W, Capecitabine: 1000 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 130mg/m² on Day1 Q3W, Maximum of 6 cycles.
BICR-PFS
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Overall Survival
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.
INV-PFS
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
BICR-ORR or INV-ORR
ORR evaluated by investigators or BICR (according to the RECIST v1.1 criteria)
BICR-DCR or INV -DCR
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
BICR-DoR or INV -DoR
DoR (based on the RECIST v1.1 criteria) evaluated by investigators or BICR
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