Overview

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

Status:
Recruiting
Trial end date:
2027-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Fifth Affiliated Hospital, Sun Yat-Sen University
Wuzhou Red Cross Hospital
Yuebei People's Hospital
Zhongshan People's Hospital, Guangdong, China
Criteria
Inclusion Criteria:

1. Histologically confirmed recurrent nasopharyngeal carcinoma.

2. The recurrence time is more than 12 months from the end of the first course of
radiotherapy.

3. Tumor staged as rT2-4N0-3M0,rII-IVa (according to the 8th AJCC edition).

4. Subjects must have a measurable disease by CT or MRI per RECIST 1.1 criteria.

5. Karnofsky scale (KPS)≥70.

6. Normal bone marrow function.

7. Normal liver and kidney function:

1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal
limit;

2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5
times the upper normal limit.

8. Given written informed consent.

Exclusion Criteria:

1. 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).

2. 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.

3. Has known allergy to large molecule protein products or any compound of study therapy.

4. Has known subjects with other malignant tumors.

5. Has any active autoimmune disease or history of autoimmune disease.

6. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.

7. The laboratory examination value does not meet the relevant standards within 7 days
before enrollment

8. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study
medication.

9. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with
adequately treated active TB with 1 year.

10. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.

11. 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.

12. Has a known history of human immunodeficiency virus (HIV).

13. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of
≥1000cps/ml or hepatitis C virus (HCV) antibody positive

14. Has received a live vaccine within 4 weeks of planned start of study therapy

15. Pregnancy or breast feeding