Clinical trial · Interventional
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| PD-1 inhibitor | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Tegafur-gimeracil-oteracil potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PD-1 inhibitor and chemoradiotherapy
- description
- PD-1 inhibitor+CapeOX/SOX/FOLFOX for 6 weeks, followed by chemoradiotherapy; 6 weeks of PD-1 inhibitor and CapeOX/SOX/FOLFOX for 6 weeks after chemoradiotherapy, followed by PD-1 inhibitor, till 12 months after chemoradiotherapy. PD-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. Chemotherapy: CapeOx or SOX or FOLFOX therapy determined by investigator. Chemoradiotherapy Radiotherapy: 1.8 Gy/fx, 45-50.5Gy Chemotherapy: Capecitabine 625mg/m2 bid orally with radiotherapy; OR Tegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy.
- interventionNames
- Drug: PD-1 inhibitor
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Tegafur-gimeracil-oteracil potassium
- Drug: 5-FU
- Radiation: Radiotherapy
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYang W, Zhou M, Li G, Zhou C, Wang L, Xia F, Zhang H, Shen L, Wang Y, Wan J, Wang Y, Zhao G, Zhang Z. Adjuvant chemoradiotherapy plus PD-1 inhibitor for pN3 gastric cancer: a randomized, multicenter, Phase III trial. Future Oncol. 2024 Dec;20(40):3389-3396. doi: 10.1080/14796694.2024.2421156. Epub 2024 Nov 15. PMID 39545610