Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Phase 2

Recruiting

• Conditions: Neoadjuvant Chemoradiotherapy; PD-1; Gastroesophageal Junction Cancer
• Interventions: Drug: PD-1inhibitor

• Registration Number: NCT06250894
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-30
• Status Verified: 2024-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-06-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant immunotherapy-chemoradiotherapy	PD-1inhibitor	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

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response	10 days after operation	No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

Secondary Outcome Measures

Name	Time	Method
Disease-Free-Survival (DFS)	Through study completion, an average of 1 year	The time between the beginning of treatment and the observation of disease progression or death from any cause.
Objective response rate (ORR)	6 months after the recruitment of the last subject.	The Objective response rate (ORR) is defined as the proportion of patients with a complete response (CR) or a partial response (PR) to preoperative therapy. The ORR will be evaluated using the RESIST1.1 protocol.
Overall survival (OS)	Through study completion, an average of 1 year	OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.
Number of participants with AEs (Adverse Events)	Through study completion, an average of 1 year	The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on. The AEs will be evaluated using the CTCAE 5.0 protocol.
Major pathologic response (MPR)	10 days after operation	defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy

Trial Locations

Locations (1)

Min Jin; 🇨🇳 Wuhan, Hubei, China