Actively Recruiting
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma
Led by Jiangxi Provincial Cancer Hospital · Updated on 2024-04-30
63
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to explore the efficacy and tolerance of local consolidative radiotherapy combined with Camrelizumab and chemotherapy in patients with oligometastatic nasopharyngeal carcinoma
CONDITIONS
Official Title
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Oligometastasis defined as 5 or fewer metastatic lesions and involvement of 2 or fewer metastatic organs
- ECOG performance status of 0 or 1, with expected survival of 6 months or more
- Good organ function including: WBC >3.0 x10^9/L; ANC >1.5 x10^9/L; Hemoglobin >90 g/L; Platelets >100 x10^9/L; Albumin 3 g/dL; liver function within specified limits; coagulation function within 1.5 times upper limit of normal; renal function with creatinine clearance 60 mL/min or serum creatinine 1.5 times upper limit of normal
- Female patients with fertility must have negative pregnancy test; female patients without fertility
- Male and female patients with fertility must agree to use effective contraception during study and for 12 months after
- Willing and able to comply with study visit schedules, treatment plans, laboratory tests, and procedures
- Willing to not participate in other drug or medical device clinical research during study
- If previously treated with chemotherapy or radiotherapy for non-metastatic disease, at least 6 months must have passed since last treatment (except for certain oral chemotherapies during progression)
- Signed informed consent form acknowledging understanding of study and hospital policies
You will not qualify if you...
- History of severe immediate hypersensitivity to any study drugs
- Other malignant tumors within 5 years except those with expected 5-year survival over 90% (e.g., non-melanoma skin cancer, pre-invasive cervical cancer)
- Cardiovascular events or conditions within 6 months before screening, including myocardial infarction, severe angina, coronary artery bypass, symptomatic heart failure, cerebrovascular accident, transient cerebral ischemia, or symptomatic pulmonary embolism
- Previous anti-PD-1 or anti-PD-L1 antibody therapy
- Use of investigational drugs within 4 weeks before starting study drug
- Use of high-dose glucocorticoids or immunosuppressants within 4 weeks before treatment (with some permitted exceptions)
- Vaccination with anti-tumor or live vaccines within 4 weeks before first administration
- Major surgery or severe trauma within 4 weeks before starting study drug
- Concurrent enrollment in another clinical study except observational or follow-up studies
- Active autoimmune disease or history of autoimmune disease that could relapse (some controlled conditions allowed)
- Active infections including tuberculosis, hepatitis B or C, HIV (with some viral load exceptions)
- Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, idiopathic pneumonia, or active pneumonia on screening CT
- Drug or alcohol addiction
- Limited legal capacity or inability to consent
- Physical or mental illness impairing understanding of study risks
- Other serious acute or chronic medical or mental conditions
- Expected survival time less than 6 months
- Significantly reduced heart, liver, lung, kidney, or bone marrow function
- Diagnosed immunodeficiency or HIV/AIDS-related diseases
- Pregnancy or lactation, or unwillingness/inability to use contraception throughout study and for 12 months afterward
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
2
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China
Actively Recruiting
3
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
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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