Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

NCT06250894 | Unknown Phase 2

• 1 other identifier: 2018S00686
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

PD-1; Neoadjuvant Chemoradiotherapy; Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

  10 days after operation

Secondary Outcomes (5)

• Objective response rate (ORR)

  6 months after the recruitment of the last subject.

• Disease-Free-Survival (DFS)

  Through study completion, an average of 1 year

• Number of participants with AEs (Adverse Events)

  Through study completion, an average of 1 year

• Major pathologic response (MPR)

  10 days after operation

• Overall survival (OS)

  Through study completion, an average of 1 year

Study Arms (1)

Neoadjuvant immunotherapy-chemoradiotherapy

EXPERIMENTAL

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

Interventions

PD-1inhibitor DRUG

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.

Neoadjuvant immunotherapy-chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Min Jin

Wuhan, Hubei, 430030, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: March 30, 2021
• Primary Completion: June 30, 2024
• Study Completion: March 30, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)