Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 2

Conditions: Gastroesophageal Junction Cancer; Neoadjuvant Chemoradiotherapy; PD-1

Treatments: Drug: PD-1inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06250894

2018S00686

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Neoadjuvant immunotherapy-chemoradiotherapy

Experimental group

Description:

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

Treatment:

Drug: PD-1inhibitor