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.
Overview
- Phase
- Phase 2
- Intervention
- Tolipalimab
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- ORR
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ming-Yuan Chen
principal investigator
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed Recurrent Nasopharyngeal Carcinoma ( the recurrence time was more than 12 months from the end of the first course of radiotherapy)
- •Patients with histologically confirmed nasopharyngeal carcinoma(WHO type II-III)
- •Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
- •Can provide either a newly obtained or archival tumor tissue sample.
- •Tumor staged as rT0-4N1-3M0 or T2-4N0M0，II-IVa (according to the 8th AJCC edition).
- •18 Years to 65 Years
- •Eastern Cooperative Oncology Group performance status ≤1
- •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).
- •Life expectancy ≥ 3months
- •Subjects must be willing to participate in the research and sign an informed consent form (ICF)
Exclusion Criteria
- •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)
- •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.
Arms & Interventions
Toripalimab +Radiotherapy
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.
Intervention: Tolipalimab
Toripalimab +Radiotherapy
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.
Intervention: Reirradiation
Outcomes
Primary Outcomes
ORR
Time Frame: Through study completion, an average of 1 year
Objective Response Rate
Secondary Outcomes
- PFS(up to 3 years)
- OS(up to 3 years)
- Incidence of Treatment-Emergent Adverse Events(Through study completion, an average of half a year)