Gastroesophageal Junction Cancer Clinical Trial
Official title:
A Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy (S-1/Oxaliplatin, SOX) and Radiotherapy for the Neoadjuvant Treatment of Locally Advanced Esophagogastric Junction Adenocarcinoma
Verified date | January 2024 |
Source | Wuhan Union Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | March 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Min Jin | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wuhan Union Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic Complete Response | No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes | 10 days after operation | |
Secondary | 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. | 6 months after the recruitment of the last subject. | |
Secondary | Disease-Free-Survival (DFS) | The time between the beginning of treatment and the observation of disease progression or death from any cause. | Through study completion, an average of 1 year | |
Secondary | 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. | Through study completion, an average of 1 year | |
Secondary | Major pathologic response (MPR) | defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy | 10 days after operation | |
Secondary | 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. | Through study completion, an average of 1 year |
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