Comparing two treatment regimens for high-risk nasopharyngeal carcinoma

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

This study is testing a new combination of treatments for patients with high-risk nasopharyngeal cancer to see if it works better than the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: camrelizumab, apatinib
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06438627 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a combination treatment regimen (TPC) consisting of nab-paclitaxel, cisplatin, and capecitabine with apatinib and camrelizumab against a standard regimen (GP) of gemcitabine and cisplatin combined with camrelizumab. It is a phase 3, multicenter, open-label trial targeting patients with high-risk regionally advanced nasopharyngeal carcinoma. The study aims to address the unmet need for effective therapies in this patient population, particularly those at high risk for distant metastasis.

Who should consider this trial

Good fit: Ideal candidates are treatment-naive adults aged 18-65 with pathologically confirmed WHO type II or III nasopharyngeal carcinoma.

Not a fit: Patients with severe organ dysfunction or known allergies to the study drugs may not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide a more effective treatment option for patients with high-risk nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promise in using combination therapies for nasopharyngeal carcinoma, but this specific approach is being evaluated for the first time.

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.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• SunYat-senU — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat sen Memorial Hospital — Guangzhou, China (Recruiting)

Study contacts

• Principal investigator: Yanqun Xiang — SunYat-sen U
• Study coordinator: Yanqun Xiang

Conditions Nasopharyngeal Carcinoma