Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

NCT04376866 | Recruiting Phase 3 DMC

• 1 other identifier: CS2020(7)
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

Recurrent Nasopharyngeal Carcinoma; Toripalimab; Concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.

  5 years

Secondary Outcomes (4)

• Progress-free survival (PFS)

  5 years

• Objective Response Rate (ORR)

  3 months

• Incidence rate of adverse events (AEs)

  5 years

• Change of QoL (quality of life)

  1 year

Study Arms (2)

Toripalimab+CCRT

EXPERIMENTAL

Toripalimab 240mg, and Cisplatin 100mg/m2 (every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT), followed by Toripalimab 240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy. IMRT: total dose 60-66Gy, 1.8-2.0Gy/f

Drug: Toripalimab

CCRT alone

NO INTERVENTION

Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT). IMRT: total dose 60-66Gy, 1.8-2.0Gy/f

Interventions

Toripalimab DRUG

anti-PD-1 antibody

Also known as: JS001

Toripalimab+CCRT

Eligibility Criteria

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

You may qualify if:

• Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
• staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
• Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
• Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
• With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
• With normal renal function test ( creatinine clearance ≥60 ml/min)
• sign an "informed consent form
• Male and no pregnant female

You may not qualify if:

• Age older than 65, or younger than 18 years old
• Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
• Patients with positive HCV antibody.
• Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
• History of interstitial lung disease
• Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
• Receive or will receive live vaccine within 30 days prior to signing the informed consent.
• Women of child-bearing potential who are pregnant or breastfeeding.
• Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
• Hypersensitivity to macromolecular protein, or to any component of triplezumab.
• HIV positive.
• Severe, uncontrolled medical conditions and infections.
• Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Sponsors & Collaborators

• Cancer Hospital of Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab

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

Study Officials

• Song Qu, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Qu, PhD

CONTACT

86-13607887386; daisyqs2002@163.com

Zhong-Guo Liang, Master

CONTACT

86-15878779785; liangzhongguo@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 6, 2020
• Study Start: June 28, 2020
• Primary Completion: April 1, 2023
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)