The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
433
Nivolumab/Toripalimab 240mg solution intravenously once daily, Q2W. OR Nivolumab/Toripalimab 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Tilelizumab/Sintilimab/Carrelizumab, 200mg solution intravenously once daily, Q3W.
CapeOx: 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off. FOLFOX: 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off.
CapeOx: 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
SOX: 40 - 60 mg bid orally in 14 days, followed by 7 days off
FOLFOX:2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W
1.8 Gy/Fx, 45-50.4 Gy
Capecitabine 625mg/m2 bid orally with radiotherapy; ORegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING3-year DFS rate
Defined as the time from randomization to the date of first documented progression or death from any cause.
Time frame: Up to 3 years
3-year OS rate
Defined as the time from randomization to death from any cause.
Time frame: Up to 3 years
3-year local recurrence free survival rate
Defined as the time from randomization to the date of first documented recurrence or death from any cause.
Time frame: Up to 3 years
Percentage of participants with treatment-related acute adverse events as assessed by CTCAE v5.0
Time frame: Up to 28 days from last dose
Quality of life as assessed by Quality of Life Scale (range 0-60)
It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Time frame: Through study completion, up to 10 years
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