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

NCT05707819 | Recruiting FDA Drug

• 1 other identifier: CS2021(124)
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Sintilimab

Keywords

Nasopharyngeal Carcinoma; Sintilimab; high risk

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  Defined from date of recruit to date of first documentation of progression or death due to any cause.

  5 years

Secondary Outcomes (6)

• Overall Survival (OS)

  5 years

• Locoregional Relapse-Free Survival (LRRFS)

  5 years

• Distant Metastasis-Free Survival (DMFS)

  5 years

• Objective Response Rate （ORR）

  through study completion, an average of 1 year

• Incidence rate of adverse events (AEs)

  5 years

Study Arms (1)

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)

Interventions

Sintilimab (PD-1 Antibody) DRUG

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.

Also known as: PD-1

Sintilimab+Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High-risk Locoregionally-advanced nasopharyngeal carcinoma

You may qualify if:

• Patients with histologically confirmed Non-keratinizing nasopharyngeal carcinoma.
• Tumor staged as III-IVA (AJCC 8th, T3-4N2-3M0).
• 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.

You may not qualify if:

• 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.
• 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.
• Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
• 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.
• Has known allergy to large molecule protein products or any compound of sintilimab.
• 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

Sponsors & Collaborators

• Cancer Hospital of Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Xiao-Dong Zhu, Doctor

  Cancer Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

• Ling Li, Master

  Cancer Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong Zhu, Doctor

CONTACT

13978873616; zhuxiaodong83@163.com

Ling Li, Master

CONTACT

15977737210; lilingmoon99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: February 1, 2023
• Study Start: July 30, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)