Nasopharyngeal Carcinoma
Conditions
Brief summary
This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
Interventions
DRUGPD-1 antibody
neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
DRUGGemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
DRUGCisplatin
neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT
RADIATIONIMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma 2. Clinical staged as T4 or N3 （according to the 8th AJCC edition） 3. No evidence of distant metastasis (M0) 4. Male and no pregnant female 5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1 6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L 7. Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN) 8. Normal renal function test ( creatinine clearance ≥60 ml/min)
Exclusion criteria
1. Recurrent or distant metastatic disease. 2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years. 3. History of radiotherapy or chemotherapy. 4. History of immunodeficiency disease 5. History of organ transplantation 6. Presence of life-threatening illness 7. Uncontrolled hypercalcemia 8. Severe uncontrolled medical conditions or active infectious diseases 9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks. 10. Pregnant or breastfeeding female 11. Emotional disturbance or mental illness 12. Refusal or inability to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress-free survival (PFS) | 3 year | From date of randomization to date of first documentation of progression or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3 year | From date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up. |
| Distant Metastasis-Free Survival (DMFS) | 3 year | From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit. |
| Locoregional Relapse-Free Survival (LRRFS) | 3 year | From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit. |
| Objective Response Rate （ORR） | within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy | Either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). |
| adverse events (AEs) | 3 year | Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0 |
Countries
China
Contacts
Primary ContactJingao Li
Backup ContactTianzhu Lu, PhD
Outcome results
None listed