Clinical trial NCT05707819: Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
Official title: Sintilimab (PD-1 Antibody) in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Multicentre, Phase 2 Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Sintilimab
Keywords: Nasopharyngeal Carcinoma
Sintilimab
high risk
Lead sponsor: Cancer Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High-risk Locoregionally-advanced nasopharyngeal carcinoma

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.

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: 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.

Eligibility 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

Primary outcomes:
measure: Progress-free survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Locoregional Relapse-Free Survival (LRRFS)
timeFrame: 5 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: 5 years
measure: Objective Response Rate （ORR）
timeFrame: through study completion, an average of 1 year
measure: Incidence rate of adverse events (AEs)
timeFrame: 5 years
measure: Serious adverse events (SAE)
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
Study officials:
affiliation: Cancer Hospital of Guangxi Medical University
name: Xiao-Dong Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital of Guangxi Medical University
name: Ling Li, Master
role: PRINCIPAL_INVESTIGATOR
References: