Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

NCT04557020 | Recruiting Phase 3 DMC

• 1 other identifier: NPC2020-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  From date of randomization to date of first documentation of progression or death due to any cause.

  3 year

Secondary Outcomes (5)

• Overall Survival (OS)

  3 year

• Distant Metastasis-Free Survival (DMFS)

  3 year

• Locoregional Relapse-Free Survival (LRRFS)

  3 year

• Objective Response Rate （ORR）

  within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy

• adverse events (AEs)

  3 year

Study Arms (2)

Arm A

EXPERIMENTAL

IC with anti-PD1 mab+CCRT+anti-PD1 mab

Drug: PD-1 antibody; Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT

Arm B

ACTIVE COMPARATOR

IC+CCRT

Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT

Interventions

PD-1 antibody DRUG

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

Arm A

Gemcitabine DRUG

neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles

Arm A; Arm B

Cisplatin DRUG

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

Arm A; Arm B

IMRT RADIATION

70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (7)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Suizhou Central Hospital

Suizhou, Hubei, China

RECRUITING

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, 341000, China

RECRUITING

First Affiliated hospital of Gannan Medical University

Guangzhou, Jiangxi, 341000, China

RECRUITING

Jiujiang University Affiliated Hospital

Jiujiang, Jiangxi, 332000, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Pingxiang Peoples' Hospital

Pingxiang, Jiangxi, 330029, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

spartalizumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jingao Li, M.D.

  Jiangxi Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingao Li

CONTACT

86-791-88300252; lijingao@hotmail.com

Tianzhu Lu, PhD

CONTACT

15270186250; lutianzhu2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 21, 2020
• Study Start: December 30, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)