A Phase 2 interventional study of PD-1inhibitor in PD-1, Neoadjuvant Chemoradiotherapy and Gastroesophageal Junction Cancer, sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Wuhan Union Hospital, China · Phase 2, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
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
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.
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
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
Plan to share: No
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Wuhan Union Hospital, China