Actively Recruiting
Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-08-26
60
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.
CONDITIONS
Official Title
Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older, male or female, who voluntarily agree and sign informed consent
- Histologically confirmed locally advanced esophageal squamous cell carcinoma at stage II-IV that is unresectable or surgery is contraindicated or refused
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- No prior systemic anti-tumor therapy including chemotherapy, radiotherapy, targeted drugs, immunotherapy, or biological therapies
- ECOG performance status of 0 or 1
- Expected survival time of 6 months or more
- Adequate vital organ function including specific blood counts, liver and kidney function within defined limits
- Women of childbearing potential must have a negative pregnancy test and use reliable contraception from consent until 3 months after last dose
You will not qualify if you...
- History of esophageal cancer surgery
- Previous fistula caused by primary tumor invasion
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation
- Poor nutritional status with more than 10% body weight loss in 2 months before screening without improvement
- Major surgery or severe trauma within 4 weeks before first study drug dose
- Uncontrollable pleural, pericardial effusion or ascites needing repeated drainage
- Prior or current treatment with anti-PD-1/PD-L1 therapy, chemotherapy, radiotherapy, targeted therapy within specified timeframes
- Use of corticosteroids over 10 mg prednisone equivalent or other immune inhibitors within 2 weeks before first drug dose, except for specific exceptions
- Recent antitumor or live vaccines within 4 weeks before first drug dose
- Active or history of autoimmune diseases excluding stable hypothyroidism or diabetes
- History of immunodeficiency, organ or bone marrow transplantation
- Uncontrolled cardiac conditions such as heart failure NYHA II or higher, unstable angina, recent myocardial infarction, or significant arrhythmias
- Severe infection within 4 weeks before first drug dose
- History of interstitial lung disease or severe pulmonary dysfunction
- Active or recent pulmonary tuberculosis
- Active hepatitis B or C infection
- Significant electrolyte abnormalities within 2 weeks before enrollment
- Allergy to study drugs or components
- Prior hematopoietic stem cell or bone marrow transplantation
- Other malignancies with high risk except certain low-risk cancers
- Any other conditions judged by researchers that may require early study termination
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, 210029
Actively Recruiting
Research Team
X
Xiaolin Ge, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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