Actively Recruiting
Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study
Led by Ruijin Hospital · Updated on 2024-07-01
26
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.
CONDITIONS
Official Title
Perioperative Treatment of Resectable Adenocarcinoma of Esophagogastric Junction by Immunotherapy (Adebrelimab) Combined With Chemotherapy (XELOX): a Prospective, Single-center, Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Histologically confirmed esophagogastric junction adenocarcinoma (Siewert Type I/II/III) with locally advanced stage considered resectable
- No previous systemic treatment for cancer
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate organ function including specific blood counts and liver, kidney, and coagulation parameters
- Male and women of childbearing age agree to use contraception from first dose until 3 months after last dose of study drug
You will not qualify if you...
- Histologically confirmed squamous cell carcinoma or mixed tumor types
- Presence of distant metastasis including peritoneal cancer or ascites unless ruled out by biopsy or laparoscopy
- Contraindications to surgical resection of esophagogastric junction cancer
- Known active autoimmune diseases or need for systemic immunosuppressive treatment
- Prior use of tumor vaccines or immune-activating anti-tumor drugs within 1 month before first dose
- Participation in other clinical trials or drug interventions within 4 weeks before first dose
- Other malignant tumors requiring treatment
- History of severe cardiovascular disease
- History of allogeneic organ or hematopoietic stem cell transplantation
- Severe allergic reactions to Adebrelimab, Capecitabine, or Oxaliplatin
- Innate or acquired immunodeficiency such as HIV, or active hepatitis B or C infection
- Other serious diseases or conditions that may affect safety or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
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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