Last updated: March 22, 2023
Sponsor: Wei Jiang
Overall Status: Active - Recruiting
Phase
2
Condition
Carcinoma
Nasopharyngeal Cancer
Treatment
N/AClinical Study ID
NCT05097209
GLMU-07
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with histologically confirmed nasopharyngeal carcinoma.
- Tumor staged as III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0).
- Eastern Cooperative Oncology Group performance status ≤1.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥80g/L and plateletcount ≥80×10e9/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 give writteninformed 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 last doseof study drug. Men who are sexually active with WOCBP must be willing to adhere toeffective contraception during treatment and for 1 year after the last dose of thestudy drug.
Exclusion
Exclusion Criteria:
- Age > 70 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, inhale ortopical corticosteroid will be allowed.
- Has a known history of active TB (bacillus tuberculosis) within 1 year; patients withadequately 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 camrelizumab.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Any other condition, including symptomatic heart failure, unstable angina, myocardialinfarction, active infection requiring systemic therapy, mental illness ordomestic/social factors, deemed by the investigator to be likely to interfere with apatient's ability to sign informed consent, cooperate and participate in the study, orinterferes with the interpretation of the results.
Study Design
Total Participants: 200
Study Start date:
April 06, 2022
Estimated Completion Date:
April 06, 2026
Study Description
Connect with a study center
Guangxi Nanxishan hospital
Guilin, Guangxi
ChinaActive - Recruiting
Guilin Medical University
Guilin, Guangxi
ChinaActive - Recruiting
Laibin People's Hospital
Laibin, Guangxi
ChinaActive - Recruiting
Linshan people's hospital
Linshan, Guangxi
ChinaActive - Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.