At a glance
ClinicalIndex Comparison Record- ✓ECOG Performance Status 0 or 1
- ✓Expected survival >6 months
- ✓Standard D2/R0 resection of stomach/GEJ
- ✓Postoperative histologically confirmed adenocarcinoma of stomach or GEJ
- ✕Gross peritoneal metastasis (CY1P0 excluded) or distant metastasis
- ✕Prior anti-tumor therapy before surgery
- ✕Prior radiotherapy to abdominal organs including stomach, liver, kidney
- ✕Active systematic autoimmune disease requiring treatment within 2 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Controlled Phase III Study of Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy as Adjuvant Regimen for D2/R0 Resected pN3 Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma
In Brief
A Phase 3 clinical trial evaluating PD-1 inhibitor, Oxaliplatin, and 5 other interventions for Gastric Cancer. Currently recruiting, targeting 433 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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