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Trial Title:
Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
NCT ID:
NCT05813626
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab (240 mg Q3W for 3 cycles) combine with chemotherapy
Arm group label:
Toripalimab Combined with Induction Chemotherapy
Summary:
Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced
nasopharyngeal carcinoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 to 65;
2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria);
3. Diagnosed with LANPC according to the 8th edition clinical staging system of the
American Joint Committee on Cancer [AJCC]/Union for International Cancer Control
[UICC];
4. ECOG performance score: 0 to 1;
5. Normal bone marrow function: white blood cell count > 4×109/L, hemoglobin > 90g/L,
platelet count > 100×109/L;
6. Normal values of thyroid function, amylase and lipase examination, pituitary
function, inflammation and infection indicators, myocardial enzymes, and ECG
results. For patients older than 50 years with a smoking history, normal lung
function are required. Patients with abnormal ECG and/or a history of vascular
disease (but not meeting the exclusion criteria listed in the exclusion criteria 7)
need further testing and require normal results of myocardial function and color
Doppler ultrasound.
7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal
(ULN); alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline
phosphatase ≤ 2.5 × ULN; creatinine clearance rate ≥ 60 ml/min;
8. Patients must sign informed consent and be willing and able to comply with the
requirements of visits, treatment, laboratory tests and other research requirements
stipulated in the research schedule;
9. Subjects with pregnancy ability must agree to use reliable contraceptive measures
from screening to 1 year after treatment.
Exclusion Criteria:
1. Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA > 1×10E3 copies/ml;
anti-hepatitis C virus positive;
2. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune
deficiency syndrome (AIDS);
3. Active tuberculosis: active tuberculosis in the past 1 year should be excluded
regardless with treatment; history of active tuberculosis over 1 year should be
excluded except that previous regulatory anti-tuberculosis treatment is proved;
4. Active, known or suspected autoimmune disease (including but not limited to uveitis,
enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism,
hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes
mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders
requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
5. Previous interstitial lung disease or pneumonia requiring oral or intravenous
steroid therapy;
6. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg
prednisone per day) or any other form of immunosuppressive therapy. Subjects who
used inhaled or topical corticosteroids were eligible;
7. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2)
unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or
ventricular arrhythmia requiring treatment or intervention;
8. Pregnant or lactating women (pregnancy test should be considered for women with
sexual life and fertility);
9. Previous or concurrent with other malignant tumors, except for adequately treated
non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
10. Allergy to macromolecular protein preparations, or any component of nivolumab;
11. Active infection requiring systemic treatment;
12. Receiving live vaccine within 30 days of the initial nivolumab;
13. History of organ transplantation;
14. History of psychotropic disease, alcoholism or drug abuse; other situation assessed
by the investigators that may compromise the safety or compliance of patients, such
as serious disease requiring timely treatment (including mental illness), severe
laboratory abnormalities, or family-social risk factors.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaozhong Chen
Phone:
571-88128202
Phone ext:
+86
Email:
cxzfyun@sina.com
Investigator:
Last name:
Caineng Cao
Email:
Sub-Investigator
Investigator:
Last name:
Shuang Huang
Email:
Sub-Investigator
Investigator:
Last name:
Mengyun Qiang
Email:
Sub-Investigator
Start date:
April 3, 2023
Completion date:
October 30, 2027
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05813626
