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Trial Title:
Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
NCT ID:
NCT06250894
Condition:
PD-1
Neoadjuvant Chemoradiotherapy
Gastroesophageal Junction Cancer
Conditions: Official terms:
Adenocarcinoma
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1inhibitor
Description:
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.
Arm group label:
Neoadjuvant immunotherapy-chemoradiotherapy
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Min Jin
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Jin
Phone:
18807108606
Email:
minjin86@126.com
Start date:
March 30, 2021
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250894
