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Safety and Efficacy of Sintilimab in Combination With Chemoradiothrapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis

NCT05002686 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-24

No results posted yet for this study

Summary

Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. The purpose of this study is to estimate safety and efficacy of Sintilimab in combination with chemoradiothrapy followed by D2 surgical resection in patients with advanced gastric cancer with retroperitoneal lymph node metastasis.

Conditions

Interventions

DRUG

Sintilimab

200 mg Q3W on Day 1 by IV infusion

DRUG

Albumin-Paclitaxel

200 mg/m\^2 Q3W on Day 1 by IV infusion

DRUG

Capecitabine

1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

DRUG

Oxaliplatin

130 mg/m\^2 Q3W on Day 1 by IV infusion

RADIATION

Radiation

Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy\*25.

PROCEDURE

Radical gastric cancer surgery

Radical gastric cancer surgery with D2 lymph node dissection

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Chen Li, PhD · Ruijin hospital affiliatted to Shanghai Jiaotong University school of medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-07
Primary Completion
2023-08-01
Completion
2024-08-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002686 on ClinicalTrials.gov