Last updated: July 18, 2021
Sponsor: Cancer Hospital of Guangxi Medical University
Overall Status: Active - Recruiting
Phase
3
Condition
Nasopharyngeal Cancer
Carcinoma
Treatment
N/AClinical Study ID
NCT04376866
CS2020(7)
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, orTwo or more image examinations (MRI, and PET-CT) show the recurrent tumor
- staged as rT3-4N0-1M0或rT1-4N2-3M0 (according to the 8th AJCC edition)
- Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
- With normal renal function test ( creatinine clearance ≥60 ml/min)
- sign an "informed consent form
- Male and no pregnant female
Exclusion
Exclusion Criteria:
- Age older than 65, or younger than 18 years old
- Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
- Patients with positive HCV antibody.
- Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism thoseonly need hormone replacement therapy, and skin disease (leukoderma, psoriasis,alopecia et al) who don't need systemic therapy can recruit.
- History of interstitial lung disease
- Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatmentswithin 28 days prior to signing the informed consent.
- Receive or will receive live vaccine within 30 days prior to signing the informedconsent.
- Women of child-bearing potential who are pregnant or breastfeeding.
- Suffered from malignant tumors, except the carcinoma in situ, papillary thyroidcarcinoma, or skin cancer (non- melanoma) within five years.
- Hypersensitivity to macromolecular protein, or to any component of triplezumab.
- HIV positive.
- Severe, uncontrolled medical conditions and infections.
- Other diseases which may influence the safety or compliance of the clinical trial,such as heart failure with symptom, unstable angina, myocardial infarction, activeinfections those need systemic therapy, mental illness, or their family and societyfactors.
Study Design
Total Participants: 204
Study Start date:
June 28, 2020
Estimated Completion Date:
April 30, 2028
Study Description
Connect with a study center
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021
ChinaActive - Recruiting

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