Clinical trial NCT04557020: Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
Official title: Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Progress-free survival (PFS)
timeFrame: 3 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 year
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: 3 year
measure: Locoregional Relapse-Free Survival (LRRFS)
timeFrame: 3 year
measure: Objective Response Rate （ORR）
timeFrame: within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
measure: adverse events (AEs)
timeFrame: 3 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Suizhou
country: China
facility: Suizhou Central Hospital
state: Hubei
city: Ganzhou
country: China
facility: Ganzhou Cancer Hospital
state: Jiangxi
city: Guangzhou
country: China
facility: First Affiliated hospital of Gannan Medical University
state: Jiangxi
city: Jiujiang
country: China
facility: Jiujiang University Affiliated Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang Peoples' Hospital
state: Jiangxi
Study officials:
affiliation: Jiangxi Provincial Cancer Hospital
name: Jingao Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: