PD-1, Neoadjuvant Chemoradiotherapy, Gastroesophageal Junction Cancer
Conditions
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.
Interventions
DRUGPD-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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response | 10 days after operation | No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
Countries
China
Outcome results
None listed