Actively Recruiting
S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2021-08-04
302
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
Sponsors
S
Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
For locally advanced adenocarcinoma of esophagogastric junction(AEG) (cT3-4aN+M0), neoadjuvant chemotherapy was improved to downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced AEG could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sintilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for several malignant tumors. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sintilimab in combination with perioperative chemotherapy in locally advanced AEG.
CONDITIONS
Official Title
S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Histological and CT/MRI confirmation of cT3-4aN+M0 esophagogastric junction adenocarcinoma
- Agreement to provide tumor tissue for PD-L1, EBV, MSI testing
- Male or female aged 18 to 75 years
- ECOG performance status 0 or 1 with no surgery contraindications
- Good physical condition and organ function suitable for abdominal and/or thoracic surgery
- Expected survival of 6 months or longer
- Adequate blood counts and liver, kidney, coagulation function as detailed in protocol
- Good compliance and ability to cooperate with study procedures and specimen collection
- Negative pregnancy test for women of childbearing age, and agreement to use contraception during study and 6 months after last dose; male participants agree to contraception during study and 6 months after last dose
You will not qualify if you...
- Other active malignant tumors within 5 years, except certain localized cured tumors
- Planned or previous organ or bone marrow transplantation
- Myocardial infarction or poorly controlled arrhythmia within 6 months before treatment
- NYHA class III to IV heart failure or left ventricular ejection fraction below 50%
- HIV infection
- Active tuberculosis
- Interstitial pneumonia, pneumoconiosis, radiation or drug-related pneumonia, or severe lung impairment
- Known active or suspicious autoimmune disease unless stable without systemic immunosuppressive therapy
- Live vaccine within 28 days before first dose, except inactivated influenza vaccine
- Use of systemic corticosteroids above 10 mg prednisone daily or other immunosuppressants within 14 days before or during study
- Active infection requiring systemic treatment within 14 days before first dose, except preventive antibiotics
- Previous immune checkpoint antibody or drug treatment
- Participation in other clinical trials with treatment ending less than 14 days before this study
- Severe allergies to monoclonal antibodies or study drug components
- History of psychotropic drug or substance abuse
- Other serious acute or chronic diseases or conditions that increase risk or impair participation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The sixth affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jun-Sheng Peng
CONTACT
S
Shi Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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