This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma.
This trial is conducted in patients with locally advanced gastric adenocarcinoma. Eligible patients will be randomized in a 1:1 ratio to receive either docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab for 4 cycles or oxaliplatin and S-1 (SOX) plus toripalimab for 3 cycles as neoadjuvant therapy. Patients who are suitable for surgery will subsequently undergo D2 gastrectomy. Within 8 weeks after surgery, eligible patients will receive postoperative DOS plus toripalimab for 4 cycles or SOX plus toripalimab for 3 cycles, according to their assigned treatment arm. After completion of the combination therapy, toripalimab will be continued every 3 weeks to complete a total duration of 1 year of adjuvant therapy, with a maximum of 17 postoperative cycles of toripalimab. Patients will be followed until death or the study cutoff date determined by the investigators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2, intravenous drip 2h, D1 and S-1 40-60mg bid, orally, D1-7 (BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid); Toripalimab, intravenous drip, 3mg/kg, D1 when combined with chemotherapy, or 240mg, D1 as monotherapy; every 14 days for a cycle during combination therapy and every 21 days for a cycle during Toripalimab monotherapy.
Oxaliplatin 130mg/m2, intravenous drip 2h, D1, combined with S-1 40-60mg bid, orally, D1-14 (BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid) and Toripalimab 240mg, intravenous drip, D1; every 21 days for a cycle.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The rate of pathologic complete response(pCR%)
Evaluation of pCR% of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
Time frame: 1 year
Progression-free Survival(PFS)
Evaluation of the Progression-free Survival of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
Time frame: 3 years
Overall Survival(OS)
Evaluation of the Overall Survival of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
Time frame: 5 years
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