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

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: TPC combined with Apatinib and Camrelizumab; Drug: GP Combined With Camrelizumab

• Registration Number: NCT06438627
• Lead Sponsor: XIANG YANQUN

Brief 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.

Detailed Description

IMPORTANCE: Safe and effective therapies for untreated, advanced locally advanced nasopharyngeal carcinoma remain an unmet need.

OBJECTIVE: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.

Study Timeline

• Study First Submitted: 2024-05-24
• Study Start: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-13
• Last Update Posted: 2024-07-16
• Primary Completion: 2026-05-30
• Study Completion: 2029-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPC+Apatinib+Camrelizumab	TPC combined with Apatinib and Camrelizumab	Radiation: IMRT Drug: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab (Induction chemotherapy)
GP+ Camrelizumab	GP Combined With Camrelizumab	Radiation: IMRT Drug: Gemcitabine, Cisplatin Combined With Camrelizumab (Induction chemotherapy)

Primary Outcome Measures

Name	Time	Method
3-years FFS	up to 3 years	3-years failure-free survival rate

Secondary Outcome Measures

Name	Time	Method
OS	up to 3 years	Overall survival rate
DMFS	up to 3 years	Distant metastasis-free survival rate
LRFS	up to 3 years	locoregional progression-free survival rate
ORR	up to 3 years	Objective response rate

Trial Locations

Locations (2)

SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat sen Memorial Hospital; 🇨🇳 Guangzhou, China