Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PD-1 Neoadjuvant Chemoradiotherapy Gastroesophageal Junction Cancer

Interventions

PD-1inhibitorDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Min Jin

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Pathologic Complete Response

No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

Time frame: 10 days after operation

Secondary Outcomes

Objective response rate (ORR)

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.

Time frame: 6 months after the recruitment of the last subject.

Disease-Free-Survival (DFS)

The time between the beginning of treatment and the observation of disease progression or death from any cause.

Time frame: Through study completion, an average of 1 year

Number of participants with AEs (Adverse Events)

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.

Time frame: Through study completion, an average of 1 year

Major pathologic response (MPR)

defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy

Time frame: 10 days after operation

Overall survival (OS)

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.

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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