NCT04557020
Recruiting
Phase 3
Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
Jiangxi Provincial Cancer Hospital7 sites in 1 country200 target enrollmentDecember 30, 2020
ConditionsNasopharyngeal Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- IMRT
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Jiangxi Provincial Cancer Hospital
- Enrollment
- 200
- Locations
- 7
- Primary Endpoint
- Progress-free survival (PFS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Arm B
IC+CCRT
Intervention: IMRT
Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
Intervention: Cisplatin
Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
Intervention: PD-1 antibody
Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
Intervention: Gemcitabine
Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
Intervention: IMRT
Arm B
IC+CCRT
Intervention: Gemcitabine
Arm B
IC+CCRT
Intervention: Cisplatin
Outcomes
Primary Outcomes
Progress-free survival (PFS)
Time Frame: 3 year
From date of randomization to date of first documentation of progression or death due to any cause.
Secondary Outcomes
- Distant Metastasis-Free Survival (DMFS)(3 year)
- Locoregional Relapse-Free Survival (LRRFS)(3 year)
- Overall Survival (OS)(3 year)
- Objective Response Rate （ORR）(within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy)
- adverse events (AEs)(3 year)
Study Sites (7)
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