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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Sintilimab (PD-1 Antibody) in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Multicentre, Phase 2 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707819
• Other study ID #: CS2021(124)
• Status: Recruiting
• Start date: July 30, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2023
• Source: Cancer Hospital of Guangxi Medical University
• Contact: Xiao-Dong Zhu, Doctor
• Phone: 13978873616
• Email: zhuxiaodong83[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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: 66~70 Gy /33f, PCTVnd: 63~64 Gy/33f, PCTV1: 60~62 Gy/33f, PCTV2: 54~56 Gy/33f. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Sintilimab

Intervention

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.

Locations

Country	Name	City	State
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	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.	5 years
Secondary	Locoregional Relapse-Free Survival (LRRFS)	Defined from date of recruit to date of first documentation of locoregional relapse or until the date of the last follow-up visit.	5 years
Secondary	Distant Metastasis-Free Survival (DMFS)	Defined from date of recruit to date of first documentation of distant metastases or until the date of the last followup visit.	5 years
Secondary	Objective Response Rate (ORR)	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).	through study completion, an average of 1 year
Secondary	Incidence rate of adverse events (AEs)	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	5 years
Secondary	Serious adverse events (SAE)	Serious adverse events (SAE) is defined as either death, life-threatening, or Permanent or severe disability/incapacity.	5 years