Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

NCT ID: NCT06250894

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2025-03-30

Brief Summary

The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.

Conditions

PD-1; Neoadjuvant Chemoradiotherapy; Gastroesophageal Junction Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant immunotherapy-chemoradiotherapy

This is a one arm study, enrolled locally advanced EGJ patients will receive Sintilimab (PD-1 inhibitor) and combined with preoperative chemoradiotherapy and operation.

generic name：PD-1; dosage form：Injection; dosage：200mg (20ml)； frequency：every 3 weeks； duration：3 times before operation and 3-5 times after operation

Group Type: EXPERIMENTAL

PD-1inhibitor

Intervention Type: DRUG

Patients receive 3 cycles of preoperative chemotherapy with Sintilimab（PD-1 inbibitor） and SOX (every 3 weeks), followed by radiotherapy (total dose of 36-40Gy in 18-22 fractions) during cycle 1 of the combination. Radical surgery for gastric cancer will be performed within 4-6 weeks after completion of neoadjuvant treatment, followed by 3-5 cycles of postoperative adjuvant chemotherapy with the SOX regimen.

Interventions

PD-1inhibitor

Patients receive 3 cycles of preoperative chemotherapy with Sintilimab（PD-1 inbibitor） and SOX (every 3 weeks), followed by radiotherapy (total dose of 36-40Gy in 18-22 fractions) during cycle 1 of the combination. Radical surgery for gastric cancer will be performed within 4-6 weeks after completion of neoadjuvant treatment, followed by 3-5 cycles of postoperative adjuvant chemotherapy with the SOX regimen.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-70, male and female.
• Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.
• No previous anti-tumor treatment.
• ECOG score was 0-1.
• Expected survival of ≥ 6 months
• Adequate organ reserve function.

Exclusion Criteria

• Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.
• Known Her-2 positive( IHC 3+ or FISH positve).
• Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody
• Severe allergic reaction to monoclonal antibody.
• Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study
• Known endoscopic signs of active bleeding from the lesion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Min Jin

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Min Jin

Role: primary

minjin86@126.com

18807108606

Other Identifiers

2018S00686

Identifier Type: -

Identifier Source: org_study_id