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

Launched by XIANG YANQUN · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with high-risk nasopharyngeal carcinoma, a type of cancer that starts in the area behind the nose. The study is comparing two treatment combinations: one that includes a regimen called TPC (which consists of three medications: nab-paclitaxel, cisplatin, and capecitabine) along with apatinib and camrelizumab, versus another regimen called GP (gemcitabine and cisplatin) combined with camrelizumab. The goal is to see which combination is more effective and safer for patients.

To be eligible for this trial, participants must be between 18 and 65 years old and have a specific type of nasopharyngeal carcinoma that has not been treated before. They should also be in reasonably good health and able to perform daily activities. Patients with certain health issues, such as severe organ problems or uncontrolled infections, may not be able to participate. Those who join the trial can expect close monitoring throughout the study and will need to give informed consent, which means they understand the trial and agree to participate. This research is important because it could lead to better treatment options for individuals facing this challenging cancer.

Gender

ALL

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.

Trial Officials