Actively Recruiting
Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-12-05
112
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.
CONDITIONS
Official Title
Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily join the study with signed informed consent and good compliance
- Unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma confirmed by histopathology
- No prior systemic treatment or recurrence after previous adjuvant or radical treatment more than 6 months ago
- At least one measurable lesion per RECIST 1.1 criteria
- Male or female patients aged between 18 and 75 years
- Eastern Oncology Cooperative Group (ECOG) performance status of 0 or 1
- Expected survival period greater than 3 months
- Adequate organ and bone marrow function meeting specified blood and biochemical test criteria
- Women of childbearing age must use contraception and have a negative pregnancy test before treatment
- Men must agree to use contraception or have surgical sterilization during the study and for 8 weeks after last dose
You will not qualify if you...
- Prior treatment with anti-EGFR monoclonal antibodies or anti-PD-1/PD-L1/CTLA-4 antibodies
- Esophageal squamous cell carcinoma causing complete obstruction requiring interventional treatment
- High risk of bleeding or perforation due to tumor invasion or existing fistulas
- Major surgery, open biopsy, or significant trauma within 28 days before enrollment
- Inability to swallow, chronic diarrhea, intestinal obstruction, or severe allergy to study drugs
- Use of traditional Chinese medicine anti-tumor treatments within 2 weeks prior to enrollment
- Liver metastases burden over 50% of liver volume
- Severe or uncontrolled illnesses including uncontrolled hypertension, significant heart conditions, active severe infections, renal failure requiring dialysis, liver diseases, poorly controlled diabetes, significant proteinuria
- Untreated wounds or fractures
- Symptomatic central nervous system metastases or cancerous meningitis
- Significant ascites or pleural effusion causing respiratory dysfunction
- Interstitial lung disease requiring steroid therapy
- Uncontrolled metabolic disorders or systemic diseases increasing medical risks
- History of psychotropic drug abuse or mental disorders
- History of immunodeficiency or organ transplantation
- Other primary malignancies except specific treated cancers without recurrence
- History of autoimmune diseases or immunosuppressive therapy
- Recent live or inactivated vaccines within 4 weeks before enrollment
- Pregnancy or lactation
- Any other serious medical condition affecting safety or study completion as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Feng Wang
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
F
Feng Wang
CONTACT
X
xiangrui Meng
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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