Last updated: June 14, 2023
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting
Phase
2
Condition
Nasopharyngeal Cancer
Carcinoma
Cancer Treatment
Treatment
Camrelizumab
Clinical Study ID
NCT04221516
NFEC-2019-184
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with histologically confirmed non-keratinizing (according to World HealthOrganization (WHO) histologically type).
- Patients with oligometastatic NPC (defined as ≤5 metastases, ≤2 organs), without localrecurrence of nasopharynx.
- Completion of radiotherapy 4-12 weeks prior to enrollment. At list one cycle ofadjuvant platinum-based chemotherapy.
- Satisfactory performance status: Karnofsky scale (KPS) > 70.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥50 ml/min.
- Expected lifetime over 3 months
- Patients must be informed of the investigational nature of this study and give writteninformed consent.
Exclusion
Exclusion Criteria:
- Previous history of autoimmune disease or unstable autoimmune disease.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, insitu cervical cancer.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CytotoxicT-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any otherantibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Active autoimmune disease requiring systemic treatment within the past 3 months or adocumented history of clinically severe autoimmune disease, or a syndrome thatrequires systemic steroids or immunosuppressive agents. Subjects with vitiligo orresolved childhood asthma/atopy are an exception to this rule. Subjects that requireintermittent use of bronchodilators or local steroid injections are not excluded fromthe study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen'ssyndrome are not excluded from the study.
- Any severe intercurrent disease, which may bring unacceptable risk or affect thecompliance of the trial, for example, unstable cardiac disease requiring treatment,renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Study Design
Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Camrelizumab
Phase: 2
Study Start date:
January 01, 2020
Estimated Completion Date:
February 01, 2024
Study Description
Connect with a study center
Southern medical university
Guangzhou, Guangdong 510515
ChinaActive - Recruiting

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