Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patien
This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive si
| Condition(s) | Gastric Cancer, Gastric Cancer Metastatic to Regional Lymph Nodes |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent ima |
| Who can participate | Inclusion criteria: * Able to provide informed consent and willing to sign an approved consent form; * age ≥ 18 years old and ≤ 75 years old, male and female; * Has histologically confirmed diagnosis of gastric or GEJ adenocarcinoma; * patients with advanced gastric cancer who have para aortic lymph node metastasis at the initial treatment and whose primary tumor site can be treated with D2 radical operation; * peritoneal exploration to exclude peritoneal metastasis, liver metastasis and other metastasis; * CT or MRI, PET-CT and other examinations suggest that there is only one unresectable factor, namely, para aortic lymph node metastasis; * has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.); * Has at least one measurable lesion as |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2024-04-01 |
| NCT ID | NCT06341595 |
| Official listing | https://clinicaltrials.gov/study/NCT06341595 |