Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This trial intends to enroll patients with T4N1 or T1-4N2-3 (AJCC 8th) locoregionally-advanced nasopharyngeal carcinoma (LANPC). All the Patients will receive 3 cycles of induction chemotherapy with docetaxel and cisplatin and cisplatin based concurrent chemoradiotherapy (CCRT) plus adjuvant immunotherapy (tisleilizumab). All patients will receive intensity-modulated radiotherapy (IMRT). Tisleilizumab will begin 4-6 weeks after CCRT and continue every 3 weeks for 12 cycles.

Official Title
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Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: a Phase 2 Trial

Conditions
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Nasopharyngeal Neoplasms

Intervention / Treatment
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* Drug: Tis-U-Sol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with histologically confirmed nasopharyngeal carcinoma. Stage T4N1 or T1-4N2-3 (AJCC 8th). 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). Patients must be informed of the investigational nature of this study and give written informed consent. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Exclusion Criteria: Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml;Hepatitis C virus (HCV) antibody positive Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed. Has a known history of interstitial lung disease. Heart disease that is not well controlled,including symptomatic heart failure, unstable angina, myocardial infarction. Is pregnant or breastfeeding. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma. Has known allergy to large molecule protein products or any compound of tisleilizumab. Has a known history of human immunodeficiency virus (HIV) infection. Active infection requiring systemic therapy. A history of psychotropic substance abuse, alcohol or drug abuse Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICRT arm<br> | Drug: Tis-U-Sol<br>* Tislelizumab 200mg will be given every 3 weeks for 12 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival (FFS) | From randomization to the date of locoregional failure, distant failure, or death from any cause. | 3 years |