Clinical trial NCT06438627: Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial
Official title: Efficacy and Safety of Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab vs Gemcitabine, Cisplatin Combined With Camrelizumab for Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Nasopharyngeal Carcinoma: A Prospective, Controlled, Open-Label, Multicenter Phase 3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: 3-years FFS
timeFrame: up to 3 years
Secondary outcomes:
measure: DMFS
timeFrame: up to 3 years
measure: OS
timeFrame: up to 3 years
measure: LRFS
timeFrame: up to 3 years
measure: ORR
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-senU
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat sen Memorial Hospital
Study officials:
affiliation: SunYat-sen U
name: Yanqun Xiang
role: PRINCIPAL_INVESTIGATOR
References: