Combining Sintilimab with Chemoradiotherapy for High-risk Nasopharyngeal Cancer
Sintilimab (PD-1 Antibody) in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Multicentre, Phase 2 Trial
This study is testing a new treatment plan that combines a cancer drug called Sintilimab with chemotherapy and radiation to see if it helps people with high-risk nasopharyngeal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 43 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cancer Hospital of Guangxi Medical University Academic / other |
| Drugs / interventions | sintilimab, prednisone, chemotherapy, radiation |
| Locations | 1 site (Nanning, Guangxi) |
| Trial ID | NCT05707819 on ClinicalTrials.gov |
What this trial studies
This program focuses on patients with high-risk locoregionally advanced nasopharyngeal carcinoma, specifically those staged as T3-4N2-3M0. Participants will undergo three cycles of induction chemotherapy using gemcitabine and cisplatin, followed by concurrent cisplatin-radiation and Sintilimab treatment. After intensity-modulated radiotherapy (IMRT), patients will continue receiving Sintilimab for an additional 11 cycles. The study aims to evaluate the efficacy and safety of this combined treatment approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed non-keratinizing nasopharyngeal carcinoma at stage T3-4N2-3M0.
Not a fit: Patients with lower-stage nasopharyngeal carcinoma or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with high-risk nasopharyngeal carcinoma.
How similar studies have performed: While there have been studies on similar combinations, this specific approach with Sintilimab in this patient population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanning, Guangxi
- Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)
Study contacts
- Principal investigator: Xiao-Dong Zhu, Doctor — Cancer Hospital of Guangxi Medical University
- Study coordinator: Xiao-Dong Zhu, Doctor
- Email: zhuxiaodong83@163.com
- Phone: 13978873616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.