Actively Recruiting
Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-04-09
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Single Arm, Prospective, Exploratory, Single Center Phase II Clinical Study to evaluate the effectiveness of the combination of Serplulimab and Concurrent Chemoradiotherapy in the treatment of elderly patients with locally advanced esophageal cancer who cannot be treated surgically.Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
CONDITIONS
Official Title
Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient voluntarily agrees to participate and signs informed consent
- Age 75 years or older, any gender
- Locally advanced esophageal squamous cell carcinoma confirmed by histology, stage II-IVa, not suitable for surgery
- PD-L1 CPS score of 1 or higher
- Presence of measurable or assessable lesions according to RECIST 1.1
- No prior systemic anti-tumor treatments
- ECOG performance status of 0 to 1
- Recommended to provide fresh or archived tumor tissue samples within 6 months for biomarker analysis
- Expected survival of at least 3 months
- Adequate organ function based on blood counts, liver, kidney tests, and coagulation parameters
You will not qualify if you...
- History of esophageal cancer surgery
- Previous fistula caused by tumor infiltration
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation
- Poor nutritional status with significant recent weight loss not improved by intervention
- Major surgery or serious trauma within 4 weeks before study drug use
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Prior treatments including anti PD-1/PD-L1 therapy, chemotherapy, radiotherapy, targeted therapy, investigational drugs within 4 weeks
- Requirement for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 2 weeks before study drug
- Use of anti-tumor or live vaccines within 4 weeks before study drug
- History of active autoimmune diseases, except stable thyroid or type I diabetes treated patients
- History of immunodeficiency, HIV positive, organ or bone marrow transplantation
- Uncontrolled heart conditions such as NYHA II or higher heart failure, recent myocardial infarction, unstable angina, or serious arrhythmias
- Recent serious infections or active pulmonary inflammation requiring antibiotics
- History of interstitial lung disease or severe pulmonary insufficiency
- Active or untreated pulmonary tuberculosis
- Active hepatitis B or C infection
- Significant lab abnormalities in sodium, potassium, or calcium not correctable
- Allergic reactions to serplulimab, paclitaxel, cisplatin, or their components
- Diagnosis of other malignant tumors with significant metastatic risk
- Other serious medical or social conditions that may affect safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009
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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