Status:
RECRUITING
Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongshan People's Hospital, Guangdong, China
Conditions:
Nasopharyngeal Carcinoma
Chemotherapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Detailed Description
Through multicenter, open-label, randomised clinical trials, patients with unresectable locally recurrent nasopharyngeal carcinoma are randomized into concurrent chemo-radiotherapy plus concurrent and...
Eligibility Criteria
Inclusion
- 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 rT2-4N0-3M0，rII-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
- 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
Key Trial Info
Start Date :
July 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT04453813
Start Date
July 3 2020
End Date
July 1 2027
Last Update
September 28 2020
Active Locations (6)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
3
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512025
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403