NCT04997837 Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
| NCT ID | NCT04997837 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 433 participants |
| Start Date | 2021-07-21 |
| Primary Completion | 2027-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 433 participants in total. It began in 2021-07-21 with a primary completion date of 2027-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Zhen Zhang, MD,PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT04997837 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04997837 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 433 participants.
Is NCT04997837 currently recruiting?
Yes, NCT04997837 is actively recruiting participants. Contact the research team at zhen_zhang@fudan.edu.cn for enrollment information.
Where is the NCT04997837 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04997837 clinical trial?
NCT04997837 is sponsored by Fudan University. The principal investigator is Zhen Zhang, MD,PhD at Fudan University. The trial plans to enroll 433 participants.
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