NCT06341595

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis: a Single-arm, Phase II, Exploratory Study.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.

Conditions

• Gastric Cancer
• Gastric Cancer Metastatic to Regional Lymph Nodes

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab: 200mg iv q3w d1, 4-6 cycles
RADIATION	Extraperitoneal radiation therapy	Radiotherapy using extraperitoneal radiation therapy, once a day, 5 times a week, 1.8-2 Gy/f, a total of 45-50.4 Gy (lymph node lesion radiation dose of 60-66 Gy)
DRUG	Oxaliplatin	oxaliplatin: 130mg/m\^2, D1, Q3W, 4-6 cycles
DRUG	S-1	S-1: 40mg/m\^2, bid, d1-14, 4-6 cycles

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: China