Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250894
• Other study ID #: 2018S00686
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastroesophageal Junction Cancer
• Neoadjuvant Chemoradiotherapy
• PD-1

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