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Clinical Trials in China / NCT05707819
Recruiting Observational

Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

NCT05707819 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Hospital of Guangxi Medical University
Phase
Observational
Started
2022-07-30
Last updated
2023-02-01

Condition(s) studied

Nasopharyngeal CarcinomaSintilimab

Investigational drug(s) / intervention(s)

Sintilimab (PD-1 Antibody)

Sintilimab (PD-1 Antibody): Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.

Study summary

The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) . Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with histologically confirmed Non-keratinizing nasopharyngeal carcinoma. 2. Tumor staged as III-IVA (AJCC 8th, T3-4N2-3M0). 3. Eastern Cooperative Oncology Group performance status ≤1. 4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. 5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. 6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula). 7. Patients must be informed of the investigational nature of this study and give written informed consent. 8. 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: * 1.Age \> 70 or \< 18. 2.Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml 3.Hepatitis C virus (HCV) antibody positive 4.Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment. 5.Has a known history of interstitial lung disease. 6.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. 7.Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. 8.Is pregnant or breastfeeding. 9.Has a history of other malignancies except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer. 10.Has known allergy to large molecule protein products or any compound of sintilimab. 11.Has a known history of human immunodeficiency virus (HIV) infection. 12.Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05707819 on ClinicalTrials.gov ↗ ← All trials in China