Gastric Cancer
Conditions
Brief 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.
Interventions
DRUGPD-1 inhibitor
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.
DRUGOxaliplatin
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.
DRUGCapecitabine
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
DRUG5-FU
FOLFOX：2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W
RADIATIONRadiotherapy
1.8 Gy/Fx, 45-50.4 Gy
DRUGChemotherapy
Capecitabine 625mg/m2 bid orally with radiotherapy; ORegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 * Patients with expected survival time more than 6 months * Patients after standard D2/R0 resection * Postoperative histologically confirmed adenocarcinoma of the stomach or GEJ * Positive lymph nodes more than 7, stage pN3 * Patients without distant metastasis (M0) or M1 with abdominal exfoliated cell detection positive (CY1P0) * Patients' physical condition and visceral function allows following adjuvant therapy, including chemotherapy, chemoradiotherapy and PD-1 inhibitor therapy. * Patients' blood routine and biochemical indicators should meet the following standard: Hb≥90g/L, ANC≥1.5\*10\^9/L, PLT≥100\*10\^9/L, ALT & AST≤2.5 U/L, TB ≤ 1.5 UNL, serum creatinine\<1 UNL. * Patients who are willing to obey regimens during the study. * Written informed consent is acquired before random entry, and patients should know that he/she has the right to quit, and following treatment won't be affected. * Patients are willing to provide samples of blood and tissue.
Exclusion criteria
* Patients with gross peritoneal metastasis (CY1P0 excluded) or distant metastasis. * Patients who has received any anti-tumor therapy before surgery. * Patients who had received radiotherapy for abdominal organs including stomach, liver, kidney, etc. * Patients who had active systematic autoimmune diseases which need systematic treatment within 2 years before first medication in the study, substitutive therapy (such as thyroxine, insulin, etc) excluded. * Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoid treatment or other immunosuppressive therapy within 7 days before medication, physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalent medication) * Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonal antibody, 5-FU, Oxaliplatin or any auxiliary material. * Patient diagnosed with other malignant tumor in the past 5 years, excluding radical basal cell carcinoma of the skin and/or radical resected carcinoma in situ. * Patient with severe vital organ failure. * Pregnant or lactation period * Patient with known mental illness or drug abuse that may influence compliance. * Patient with known HIV infection, or active tuberculosis. * Untreated active hepatitis B * Patient with active HCV infection * Uncontrolled complications * Other situations that might disturb study results and compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year DFS rate | Up to 3 years | Defined as the time from randomization to the date of first documented progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year OS rate | Up to 3 years | Defined as the time from randomization to death from any cause. |
| 3-year local recurrence free survival rate | Up to 3 years | Defined as the time from randomization to the date of first documented recurrence or death from any cause. |
| Percentage of participants with treatment-related acute adverse events as assessed by CTCAE v5.0 | Up to 28 days from last dose | — |
| Quality of life as assessed by Quality of Life Scale (range 0-60) | 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. |
Countries
China
Contacts
Primary ContactZhen Zhang, MD, PhD
Outcome results
None listed