Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Squamous Cell Carcinoma, Toripalimab
Conditions
Keywords
Nasopharyngeal Carcinoma, Toripalimab
Brief summary
This is a prospective, single-arm, phase II trial to study the efficacy of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
Interventions
DRUGToripalimab
Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 2 weeks after CCRT
Sponsors
Cancer Hospital of Guangxi Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrence tumor 2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition） 3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1 4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L 5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN) 6. With normal renal function test ( creatinine clearance ≥60 ml/min) 7. sign an informed consent form 8. Male and no pregnant female
Exclusion criteria
1. Age\> 70, or \< 18 years old 2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml. 3. Patients with positive HCV antibody. 4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit. 5. History of interstitial lung disease 6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent. 7. Receive or will receive live vaccine within 30 days prior to signing the informed consent. 8. Women of child-bearing potential who are pregnant or breastfeeding. 9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years. 10. Hypersensitivity to macromolecular protein, or to any component of triplezumab. 11. HIV positive. 12. Severe, uncontrolled medical conditions and infections. 13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress-free survival (PFS) | 2 years | Defined from date of randomization to date of first documentation of progression or death due to any cause. |
| Objective Response Rate （ORR） | After the completion of the PD-1 antibody and chemoradiotherapy treatment | An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). |
| Incidence rate of adverse events (AEs) | 2 years | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 |
| Change of QoL (quality of life) | 1 year | QoL scores were assessed by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before radiotherapy, at the end of radiotherapy, at 12 months after radiotherapy. |
Countries
China
Outcome results
None listed