Actively Recruiting
Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma
Led by Sun Yat-sen University · Updated on 2025-06-12
37
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (Tegafur+Oxaliplatin) for locally advanced esophagogastric junction adenocarcinoma.
CONDITIONS
Official Title
Neoadjuvant Immunochemotherapy in Locally Advanced Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced esophagogastric junction adenocarcinoma cT3-4aN0 or T1-4aN1-3M0
- No previous anti-tumor treatment
- ECOG performance status 0-1
- Adequate organ function including neutrophil count 1.5 10^9/L, platelet count 90 10^9/L, hemoglobin 9 g/dl, serum albumin 3 g/dl, normal thyroid function, bilirubin, ALT, AST, AKP, and creatinine within defined limits
- Women of childbearing potential must use reliable contraception and have a negative pregnancy test within 7 days before enrollment
- Men must agree to use contraception or surgical sterilization during the trial and for 8 weeks after last drug administration
- Voluntary informed consent and good compliance with study follow-up
You will not qualify if you...
- Known Her-2 positive status
- Any active autoimmune disease or history of autoimmunity except fully resolved vitiligo or childhood asthma not requiring treatment
- Severe allergic reaction to monoclonal antibodies
- Neutrophil count less than 1500/mm3
- Uncontrolled cardiac symptoms or diseases
- Prior radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy
- Innate or acquired immunodeficiency or active hepatitis B or C infection
- Other serious diseases or conditions that could interfere with study participation or safety
- High risk of esophageal perforation or surgery not possible as judged by imaging or endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hong Yang, M.D. Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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