Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) locoregionally advanced nasopharyngeal carcinoma (LANPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab (200mg q3wk), and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. IMRT:PGTVnx: 69.96 Gy /33f, PGTVnd: 6670 Gy /33f, PCTVnd: 6364 Gy/33f, PCTV1: 6062 Gy/33f, PCTV2: 5456 Gy/33f. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Sintilimab+Chemoradiotherapy 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. |
Drug: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Progress-free survival (PFS) [5 years]
Defined from date of recruit to date of first documentation of progression or death due to any cause.
Secondary Outcome Measures
- Overall Survival (OS) [5 years]
Defined from date of recruit to date of first documentation of death from any cause or censored at the date of the last follow-up.
- Locoregional Relapse-Free Survival (LRRFS) [5 years]
Defined from date of recruit to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
- Distant Metastasis-Free Survival (DMFS) [5 years]
Defined from date of recruit to date of first documentation of distant metastases or until the date of the last followup visit.
- Objective Response Rate (ORR) [through study completion, an average of 1 year]
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) [5 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
- Serious adverse events (SAE) [5 years]
Serious adverse events (SAE) is defined as either death, life-threatening, or Permanent or severe disability/incapacity.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histologically confirmed Non-keratinizing nasopharyngeal carcinoma.
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Tumor staged as III-IVA (AJCC 8th, T3-4N2-3M0).
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Eastern Cooperative Oncology Group performance status ≤1.
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Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
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Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
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Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
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Patients must be informed of the investigational nature of this study and give written informed consent.
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Guangxi Medical University Cancer Hospital | Nanning | Guangxi | China | 530021 |
Sponsors and Collaborators
- Cancer Hospital of Guangxi Medical University
Investigators
- Principal Investigator: Xiao-Dong Zhu, Doctor, Cancer Hospital of Guangxi Medical University
- Principal Investigator: Ling Li, Master, Cancer Hospital of Guangxi Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS2021(124)