Brief Title
IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.
Official Title
A Single Center 、Single Arm Phase I/II Clinical Trial of Intensity-modulated Radiotherapy Combined With Toripalimab in the Treating of Unresectable Locally Recurrent Nasopharyngeal Carcinoma.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of intensity-modulated
radiation therapy combined with toripalimab in patients with the unresectable locally
recurrent nasopharyngeal carcinoma.
Detailed Description
This is an open-label ,single center ,non-randomized, single arm exploratory study. All
eligible patients presented with non-keratinizing NPC and stage rT0-4N1-3M0 /rT2-4N0M0 are
assigned to receive IMRT combined with toripalimab.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
ORR
Secondary Outcome
PFS
Condition
Nasopharyngeal Carcinoma
Intervention
Tolipalimab
Study Arms / Comparison Groups
Toripalimab +Radiotherapy
Description: Radiotherapy, intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks ) will be administered as an intravenous infusion over 60 minutes.
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
25
Start Date
May 1, 2019
Completion Date
October 31, 2020
Primary Completion Date
June 30, 2020
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed Recurrent Nasopharyngeal Carcinoma ( the recurrence time was
more than 12 months from the end of the first course of radiotherapy)
2. Patients with histologically confirmed nasopharyngeal carcinoma(WHO type II-III)
3. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
4. Can provide either a newly obtained or archival tumor tissue sample.
5. Tumor staged as rT0-4N1-3M0 or T2-4N0M0，II-IVa (according to the 8th AJCC edition).
6. 18 Years to 65 Years
7. Eastern Cooperative Oncology Group performance status ≤1
8. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet
count ≥100×10e9/L.Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST)
≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. Adequate renal function:
creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
9. Life expectancy ≥ 3months
10. Subjects must be willing to participate in the research and sign an informed consent
form (ICF)
11. Female of child bearing potential, a negative urine or serum pregnancy test result
within 72 h before study treatment. Participants of reproductive potential must be
willing to use adequate contraception for the course of the study through 60 days
after the last dose of Toripalimab.
12. Male subjects with WOCBP partner must be willing to use adequate contraception for the
course of the study through 120 days after the last dose of Toripalimab.
Exclusion Criteria:
1. operable recurrence of nasopharyngeal cancer: rT1N0M0 rT2N0M0 (the tumour was confined
in the superficial parapharyngeal spacer) rT3N0M0 (the tumour was confined in the base
wall of the sphenoid sinus) rT0N1-3M0 (the tumour was not invasion into the cervical
vertebrae, brachial plexus, deep muscles of the neck, or carotid artery)
2. Has known allergy to large molecule protein products or any compound of study therapy
3. Has known Subjects with other malignant tumors
4. Has any active autoimmune disease or history of autoimmune disease
5. Has a history of psychiatric substance abuse, alcoholism, or drug addiction;
6. the laboratory examination value does not meet the relevant standards within 7 days
before enrollment
7. Received a systematic Glucocorticoid therapy within 4 weeks of the first dose of study
medication.
8. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with
adequately treated active TB with 1 year.
9. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
10. 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.
11. Has a known history of human immunodeficiency virus (HIV).
12. Has hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody
positive
13. Has received a live vaccine within 4 weeks of planned start of study therapy
14. Pregnancy or breast feeding
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Ming-Yuan Chen, MD,PhD, +86-20-87343361, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03854838
Organization ID
2019-FXY-020
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Ming-Yuan Chen, MD,PhD, Principal Investigator, Sun Yat-sen University
Verification Date
March 2020