Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
NCT ID: NCT04557020
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2020-12-30
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
PD-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
Gemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
Cisplatin
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
IMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Arm B
IC+CCRT
Gemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
Cisplatin
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
IMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Interventions
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PD-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
Gemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
Cisplatin
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
IMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
69 Years
ALL
No
Sponsors
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Jiangxi Provincial Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Jingao Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jiangxi Provincial Cancer Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Dongsheng Zhang, MD
Role: primary
Wei Wu, M.D.
Role: primary
Mingjun Xu, MD
Role: primary
Renwang Chen
Role: backup
Zhaohui Leng, MD
Role: primary
Fan Cai, MD
Role: primary
Other Identifiers
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NPC2020-001
Identifier Type: -
Identifier Source: org_study_id
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