Brief Title
Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
Official Title
A Multicenter Randomized Clinical Phase 3 Trial of Toripalimab Plus Concurrent Chemo-radiotherapy vs Concurrent Chemo-radiotherapy Alone for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
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 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.
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 adjuvant PD-1 treatment group and concurrent chemo-radiotherapy alone
group. The efficacy and safety of patients between these two groups are compared.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progress-free survival (PFS)
Secondary Outcome
Overall Survival (OS)
Condition
Nasopharyngeal Carcinoma
Intervention
Toripalimab plus concurrent chemo-radiotherapy
Study Arms / Comparison Groups
Toripalimab plus concurrent chemo-radiotherapy arm
Description: Concurrent chemo-radiotherapy plus concurrent and adjuvant toripalimab.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
226
Start Date
July 3, 2020
Completion Date
July 2027
Primary Completion Date
July 2025
Eligibility 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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, : 86-20-87343624, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04453813
Organization ID
SYSUCC-MYC-2020-2101
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Sponsor
, ,
Verification Date
September 2020