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Trial Title:
Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma
NCT ID:
NCT05707819
Condition:
Nasopharyngeal Carcinoma
Sintilimab
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Antibodies
Conditions: Keywords:
Nasopharyngeal Carcinoma
Sintilimab
high risk
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab (PD-1 Antibody)
Description:
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.
Arm group label:
Sintilimab+Chemoradiotherapy
Other name:
PD-1
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.
Criteria for eligibility:
Study pop:
High-risk Locoregionally-advanced nasopharyngeal carcinoma
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ling Li, MD
Phone:
8615977737210
Email:
lilingmoon99@163.com
Start date:
July 30, 2022
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Cancer Hospital of Guangxi Medical University
Agency class:
Other
Source:
Cancer Hospital of Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05707819
