Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma

Who is this study for? Patients with high-risk nasopharyngeal carcinoma
What treatments are being studied? PD-1 antibody+Gemcitabine+Cis Platinum+IMRT
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fuzhou
Ganzhou Cancer Hospital
RECRUITING
Ganzhou
First Affiliated hospital of Gannan Medical University
RECRUITING
Guangzhou
Jiujiang University Affiliated Hospital
RECRUITING
Jiujiang
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Pingxiang Peoples' Hospital
RECRUITING
Pingxiang
Suizhou Central Hospital
RECRUITING
Suizhou
Contact Information
Primary
Jingao Li
lijingao@hotmail.com
86-791-88300252
Backup
Tianzhu Lu, PhD
lutianzhu2008@163.com
15270186250
Time Frame
Start Date: 2020-12-30
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 200
Treatments
Experimental: Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
Active_comparator: Arm B
IC+CCRT
Authors
Kairong Huang, Xiaojun Zhong
Related Therapeutic Areas
Sponsors
Leads: Jiangxi Provincial Cancer Hospital

This content was sourced from clinicaltrials.gov

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