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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250894
Other study ID # 2018S00686
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 30, 2021
Est. completion date March 30, 2025

Study information

Verified date January 2024
Source Wuhan Union Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
China Min Jin Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

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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