Phase
Condition
Nasopharyngeal Cancer
Treatment
Gemcitabine
QL1706
Cisplatin
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with histologically confirmed nasopharyngeal carcinoma.
Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th).
Eastern Cooperative Oncology Group performance status ≤1.
Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L andplatelet count ≥100×10e9/L.
Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit ofnormal (ULN), and bilirubin ≤ 1.5×ULN.
Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gaultformula).
Patients must be informed of the investigational nature of this study and givewritten informed consent.
Women of childbearing potential (WOCBP) who are sexually active must be willing toadhere to effective contraception during treatment and for 1 year after the lastdose of study drug. Men who are sexually active with WOCBP must be willing to adhereto effective contraception during treatment and for 1 year after the last dose ofthe study drug
Exclusion
Exclusion Criteria:
Age > 65 or < 18.
Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3copies/ml or 200IU/ml
Hepatitis C virus (HCV) antibody positive
Has active autoimmune disease, except type I diabetes, hypothyroidism treated withreplacement therapy, and skin disease that doesn't require systemic treatment (e.g.,vitiligo, psoriasis, or alopecia).
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, inhaleor topical corticosteroid will be allowed.
Has a known history of active TB (bacillus tuberculosis) within 1 year; patientswith adequately treated active TB over 1 year ago will be allowed.
Has a known history of interstitial lung disease.
Has received a live vaccine within 30 days before informed consent or will receive alive vaccine in the near future.
Is pregnant or breastfeeding.
Prior malignancy within 5 years, except in situ cancer, adequately treatednon-melanoma skin cancer, and papillary thyroid carcinoma.
Has known allergy to large molecule protein products or any compound of QL1706.
Has a known history of human immunodeficiency virus (HIV) infection.
Any other condition, including symptomatic heart failure, unstable angina,myocardial infarction, active infection requiring systemic therapy, mental illnessor domestic/social factors, deemed by the investigator to be likely to interferewith a patient's ability to sign informed consent, cooperate and participate in thestudy, or interferes with the interpretation of the results.
Study Design
Study Description
Connect with a study center
Fujian Cancer Hospital
Fuzhou,, Fujian
ChinaSite Not Available
Dongguan People's Hospital
Dongguan, Guangdong
ChinaSite Not Available
First People's Hospital of Foshan
FoShan, Guangdong
ChinaSite Not Available
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
GuangZhou, Guangdong 510060
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
GuangZhou, Guangdong 510060
ChinaActive - Recruiting
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong 510060
ChinaSite Not Available
Zhongshan People's Hospital
Zhongshan, Guangdong
ChinaSite Not Available
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi 530000
ChinaSite Not Available
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou
ChinaSite Not Available
Hubei Province Cancer Hosiptal
WuHan, Hubei 430000
ChinaSite Not Available
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
WuHan, Hubei 430000
ChinaSite Not Available
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430000
ChinaSite Not Available
Hunan Cancer Hospital
ChangSha, Hunan 410000
ChinaSite Not Available
Xiangya Hospital of Central South University
ChangSha, Hunan
ChinaSite Not Available
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