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Clinical Trials in China / NCT06438627
Recruiting Phase 3

Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial

NCT06438627 · tracked via the Priya Life Science China tracker
Sponsor
XIANG YANQUN
Phase
Phase 3
Started
2024-05-30
Last updated
2024-07-16

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

TPC combined with Apatinib and CamrelizumabGP Combined With CamrelizumabAll GP trials (8) →All Camrelizumab trials (56) →

TPC combined with Apatinib and Camrelizumab: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab

GP Combined With Camrelizumab: Gemcitabine, Cisplatin regimen Combined With Camrelizumab

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Pathologically confirmed WHO type II or III; 2. Staging TanyN3M0 (UICC/AJCC 8th edition); 3. Treatment-naive patients with no history of other malignancies; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5. Age 18-65 years; 6. Neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L, transaminases \<2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal, creatinine \<1.5 times the upper limit of normal; activated partial thromboplastin time and international normalized ratio \<1.5 times the upper limit of normal; 7. Signed informed consent form. Exclusion Criteria: 1. Known or suspected allergy to the study drugs, or pregnant/perinatal women; 2. Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons; 3. Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance to chemoradiotherapy; 4. Severe uncontrolled infection or internal medical disease; 5. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml, exclusion if normal liver function and on antiviral medication for more than one week; hepatitis C defined as HCV-RNA above the lower limit of detection) or coinfection with hepatitis B and C; 6. Factors affecting drug administration, distribution, metabolism, or excretion such as psychiatric disorders, central nervous system abnormalities, chronic diarrhea, ascites, or pleural effusion; 7. Poorly controlled hypertension despite antihypertensive treatment (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg); 8. Long-term use of immunosuppressants post-organ transplantation; 9. Known history of substance abuse or drug addiction; 10. History of other malignancies prior to enrollment; 11. Presence of other severe physical or mental illnesses or abnormal laboratory findings that may increase the risk of study participation, interfere with study results, or deemed unsuitable for participation by the investigator.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
SunYat-senU Guangzhou Guangdong Recruiting
Sun Yat sen Memorial Hospital Guangzhou China Recruiting

More XIANG YANQUN trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06438627 on ClinicalTrials.gov ↗ ← All trials in China