Actively Recruiting
Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.
Led by Fujian Cancer Hospital · Updated on 2023-10-19
75
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.
CONDITIONS
Official Title
Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and voluntarily participate in this study
- Diagnosed with esophageal squamous cell carcinoma confirmed by histopathology or immunohistochemistry
- UICC/AJCC TNM stage IVA or oligometastatic stage IVB
- Expected survival longer than 3 months
- Age between 18 and 75 years
- ECOG performance status of 0 to 2
- No prior systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted or immunotherapy
- At least one measurable lesion
- Normal function of major organs, including blood counts (white blood cells ≥ 3.0 x10^9/L, neutrophils ≥ 1.0 x10^9/L, platelets ≥ 80 x10^9/L, hemoglobin ≥ 80 g/L)
- Blood biochemistry within acceptable limits (total bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5 x ULN, serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 45 mL/min)
- Good compliance and willingness to cooperate with follow-up
You will not qualify if you...
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Poor nutritional status with BMI less than 18.5 Kg/m^2 unless corrected by nutritional support before enrollment
- Gastrointestinal bleeding exceeding 200 ml per day
- Presence of deep ulcers as determined by the investigator
- Previous allergy to monoclonal antibodies or any components of camrelizumab, paclitaxel, cisplatin, or other platinum drugs
- Prior or current treatment with radiation, chemotherapy, or other anti-tumor drugs for the tumor
- Use of immunosuppressive agents or systemic hormones for immunosuppression exceeding 10 mg/day prednisone or equivalent within 2 weeks before study drug use
- Receipt of live attenuated vaccine within 4 weeks prior to study drug administration
- Major surgery or severe trauma within 4 weeks before study drug use
- History of active autoimmune diseases or immunodeficiency conditions including HIV or organ transplantation
- Poorly controlled cardiac symptoms or diseases such as heart failure NYHA II or above, unstable angina, recent myocardial infarction, or uncontrolled arrhythmias
- Severe infection within 4 weeks before study drug use or active pulmonary inflammation within 14 days
- Active pulmonary tuberculosis infection or history without regular treatment
- Active hepatitis B or C infection as defined by viral load or antibody status
- Other serious medical conditions, mental illness, substance abuse, or factors affecting safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
Research Team
J
Jiancheng Li, Doctor
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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