Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Registration Number
- NCT04557020
- Lead Sponsor
- Jiangxi Provincial Cancer Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
- Clinical staged as T4 or N3 （according to the 8th AJCC edition）
- No evidence of distant metastasis (M0)
- Male and no pregnant female
- ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
- Normal renal function test ( creatinine clearance ≥60 ml/min)
- Recurrent or distant metastatic disease.
- History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- History of radiotherapy or chemotherapy.
- History of immunodeficiency disease
- History of organ transplantation
- Presence of life-threatening illness
- Uncontrolled hypercalcemia
- Severe uncontrolled medical conditions or active infectious diseases
- Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
- Pregnant or breastfeeding female
- Emotional disturbance or mental illness
- Refusal or inability to sign informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A IMRT IC with anti-PD1 mab+CCRT+anti-PD1 mab Arm A PD-1 antibody IC with anti-PD1 mab+CCRT+anti-PD1 mab Arm B Cisplatin IC+CCRT Arm B IMRT IC+CCRT Arm B Gemcitabine IC+CCRT Arm A Gemcitabine IC with anti-PD1 mab+CCRT+anti-PD1 mab Arm A Cisplatin IC with anti-PD1 mab+CCRT+anti-PD1 mab
- Primary Outcome Measures
Name Time Method Progress-free survival (PFS) 3 year From date of randomization to date of first documentation of progression or death due to any cause.
- Secondary Outcome Measures
Name Time Method 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.
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.
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
Trial Locations
- Locations (7)
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Suizhou Central Hospital
🇨🇳Suizhou, Hubei, China
Ganzhou Cancer Hospital
🇨🇳Ganzhou, Jiangxi, China
First Affiliated hospital of Gannan Medical University
🇨🇳Guangzhou, Jiangxi, China
Jiujiang University Affiliated Hospital
🇨🇳Jiujiang, Jiangxi, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Pingxiang Peoples' Hospital
🇨🇳Pingxiang, Jiangxi, China