Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Jul 5, 2027
  • participants needed
    226
  • sponsor
    Sun Yat-sen University
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Updated on 5 August 2020
See if I qualify
measurable disease
nasopharyngeal carcinoma
karnofsky performance status
carcinoma
toripalimab
chemo-radiotherapy
creatinine clearance rate
recurrent nasopharyngeal carcinoma
adjuvant
recurrent nasopharyngeal cancer

Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.

Description

Through multicenter, open-label, randomised clinical trials, patients with unresectable locally recurrent nasopharyngeal carcinoma are randomized into concurrent chemo-radiotherapy plus concurrent and adjuvant PD-1 treatment group and concurrent chemo-radiotherapy alone group. The efficacy and safety of patients between these two groups are compared.

Details
Condition Chemotherapy, Chemotherapy, Radiation Oncology, Carcinoma, vulvar dysplasia and carcinoma, drug therapy, Radiotherapy, radiotherapeutic, Nasopharyngeal Cancer, Nasopharyngeal Cancer, vulvar dysplasia and carcinoma, PD-1 Treatment
Age 18years - 70years
Treatment Toripalimab plus concurrent chemo-radiotherapy, Concurrent chemo-radiotherapy
Clinical Study IdentifierNCT04453813
SponsorSun Yat-sen University
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically confirmed recurrent nasopharyngeal carcinoma
The recurrence time is more than 12 months from the end of the first course of radiotherapy
Tumor staged as rT2-4N0-3M0rII-IVa (according to the 8th AJCC edition)
Subjects must have a measurable disease by CT or MRI per RECIST 1.1 criteria
Karnofsky scale (KPS)70
Normal bone marrow function
Normal liver and kidney function
total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit
creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit
Given written informed consent

Exclusion Criteria

Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal carotid artery) and rT3 (the tumour is confined in the base wall of the sphenoid sinus and is more than 0.5cm from the internal carotid artery and cavernous sinus)
The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as unsuitable for secondary radiotherapy by the researchers
Has known allergy to large molecule protein products or any compound of study therapy
Has known subjects with other malignant tumors
Has any active autoimmune disease or history of autoimmune disease
Has a history of psychiatric substance abuse, alcoholism, or drug addiction
The laboratory examination value does not meet the relevant standards within 7 days before enrollment
Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication
Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent
Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll
Has a known history of human immunodeficiency virus (HIV)
Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of 1000cps/ml or hepatitis C virus (HCV) antibody positive
Has received a live vaccine within 4 weeks of planned start of study therapy
Pregnancy or breast feeding
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measurable disease
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chemo-radiotherapy
creatinine clearance rate
recurrent nasopharyngeal carcinoma
adjuvant
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