Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
NCT Number: NCT04997837
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Up to 3 years
Defined as the time from randomization to the date of first documented progression or death from any cause.
Time frame: Up to 3 years
Defined as the time from randomization to death from any cause.
Time frame: Up to 3 years
Defined as the time from randomization to the date of first documented recurrence or death from any cause.
Time frame: Up to 28 days from last dose
Time frame: Through study completion, up to 10 years
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.
Contact information is provided by the study sponsor or research team.
Fudan University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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