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

Phase 2

Recruiting

• Conditions: Gastric Cancer; Gastric Cancer Metastatic to Regional Lymph Nodes
• Interventions: Drug: Sintilimab; Radiation: Extraperitoneal radiation therapy; Drug: Oxaliplatin; Drug: S-1

• Registration Number: NCT06341595
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Status Verified: 2024-01
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study Start: 2024-04-01
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combination therapy	Sintilimab	sintilimab combined with chemotherapy and radiotherapy
combination therapy	Oxaliplatin	sintilimab combined with chemotherapy and radiotherapy
combination therapy	Extraperitoneal radiation therapy	sintilimab combined with chemotherapy and radiotherapy
combination therapy	S-1	sintilimab combined with chemotherapy and radiotherapy

Primary Outcome Measures

Name	Time	Method
Recurrence free survival (RFS)	24 months	Recurrence free survival of patients undergoing surgery after Sintilimab Injection combined with concurrent chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	24 months	According to the adverse event data of CTCAE version 5.0
Overall survival (OS)	24 months	Median survival time of all subjects from enrollment to death from any cause
R0 resection rate	12 months	Proportion of patients with R0 resection who underwent surgery in all enrolled patients.
Major pathological response rate (MPR)	12 months	Proportion of patients with residual survival tumor ≤ 10% in all enrolled patients during surgery
Objective response rate (ORR)	24 months	Proportion of participants in complete and partial remission

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China