Adjuvant chemotherapy with or without PD-1 inhibitors for gastric cancer
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
This study is testing if adding PD-1 inhibitors to chemotherapy and radiation after surgery can help people with advanced stomach cancer live longer and stay cancer-free compared to just chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 433 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04997837 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of postoperative adjuvant chemotherapy combined with PD-1 inhibitors and chemoradiotherapy compared to chemotherapy alone in patients with resected pN3 gastric or gastroesophageal junction adenocarcinoma. A total of 433 patients will be enrolled, with one group receiving PD-1 inhibitors alongside chemotherapy and chemoradiotherapy, while the other group will receive only chemotherapy. The primary outcomes measured will include disease-free survival and overall survival, as well as the assessment of adverse effects associated with the treatments.
Who should consider this trial
Good fit: Ideal candidates are patients with resected pN3 gastric or gastroesophageal junction adenocarcinoma who have a good performance status and no distant metastasis.
Not a fit: Patients with distant metastasis or those with a poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and treatment outcomes for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in similar cancer types, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Zhang, MD,PhD — Fudan University
- Study coordinator: Zhen Zhang, MD, PhD
- Email: zhen_zhang@fudan.edu.cn
- Phone: 18801735029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.