Comparing two chemotherapy regimens with Camrelizumab for advanced nasopharyngeal carcinoma
Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study
PHASE3 · Sun Yat-sen University · NCT06669611
This study is testing whether two different chemotherapy treatments combined with the immunotherapy drug Camrelizumab can help people with advanced nasopharyngeal cancer live longer and feel better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, Camrelizumab, pembrolizumab, Carilizumab, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06669611 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of two chemotherapy regimens, nab-TPC and GP, when combined with the immunotherapy drug Camrelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma. The study will compare the therapeutic effects of these combinations, focusing on patient survival and side effects. Previous studies have indicated that anti-PD-1 inhibitors like Camrelizumab can significantly improve outcomes in this patient population, making this trial particularly relevant. The trial is designed as a phase III study, indicating a robust approach to assess the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with recurrent or metastatic nasopharyngeal carcinoma and an ECOG performance status of 0-1.
Not a fit: Patients who have not had at least 4 weeks since their last chemotherapy or those with significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar approaches using immunotherapy in treating metastatic nasopharyngeal carcinoma, indicating a potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age over 18 years. 2. ECOG score of 0-1. 3. Expected survival of at least 12 weeks. 4. Recurrent/Metastatic Nasopharyngeal Carcinoma. 5. At least 4 weeks since the previous chemotherapy. 6. At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions. 7. had adequate organ function
Where this trial is running
Guangzhou, Guangdong
- SunYat-senU — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: XIANG YANQUN
- Email: xiangyq@sysucc.org.cn
- Phone: 02087343379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasopharyngeal Cancinoma