Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma
This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
| Condition(s) | Recurrent Nasopharyngeal Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma. |
| Who can participate | Inclusion Criteria: 1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor 2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition） 3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1 4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L 5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN) 6. With normal renal function test ( creatinine clearance ≥60 ml/min) 7. sign an "informed consent form 8. Male and no pregnant female Exclusion Criteria: 1. Age older than 65, or younger than 18 years old 2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml. 3. Patients with positive HCV antibo |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Cancer Hospital of Guangxi Medical University |
| Locations | Nanning, Guangxi, China |
| Start date | 2020-06-28 |
| NCT ID | NCT04376866 |
| Official listing | https://clinicaltrials.gov/study/NCT04376866 |