Actively Recruiting
Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial
Led by XIANG YANQUN · Updated on 2024-07-16
164
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.
CONDITIONS
Official Title
Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed WHO type II or III nasopharyngeal carcinoma
- Staging TanyN3M0 according to UICC/AJCC 8th edition
- No prior treatment and no history of other cancers
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Age between 18 and 65 years
- Adequate blood cell counts and organ function as specified
- Signed informed consent form
You will not qualify if you...
- Allergy to study drugs or pregnancy/perinatal status
- Inability to comply with follow-up due to psychological, social, family, or geographic reasons
- Severe heart, lung, liver, or kidney dysfunction preventing chemoradiotherapy
- Severe uncontrolled infection or internal medical diseases
- HIV infection, known AIDS, untreated active hepatitis B or C, or coinfection
- Conditions affecting drug metabolism such as psychiatric disorders, CNS abnormalities, chronic diarrhea, ascites, or pleural effusion
- Poorly controlled hypertension despite treatment
- Long-term immunosuppressant use after organ transplantation
- History of substance abuse or drug addiction
- History of other malignancies before enrollment
- Severe physical or mental illnesses or abnormal labs increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
SunYat-senU
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Sun Yat sen Memorial Hospital
Guangzhou, China
Actively Recruiting
Research Team
Y
Yanqun Xiang
CONTACT
G
Guoying Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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