Last updated: March 23, 2022
Sponsor: Fudan University
Overall Status: Active - Recruiting
Phase
2
Condition
Carcinoma
Nasopharyngeal Cancer
Chemotherapy
Treatment
N/AClinical Study ID
NCT04921995
2021052-1
Ages 15-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed as local recurrence ± regional recurrence after ≥1 year of radicaltreatment;
- Not suitable for surgery;
- Clinical stage rT3-4N0-2 (rII-IVa, AJCC/UICC 8th);or residual disease afer surgery.
- ECOG score 0-1;
- No prior treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy orbiotherapy;
- No contraindications to immunotherapy or chemoradiotherapy;
- Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L,PLT count ≥ 100×10E9/L;
- Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
- Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Take effective contraceptions during and two months after treatment;
- Patients must be informed of the investigational nature of this study and give writteninformed consent.
Exclusion
Exclusion Criteria:
- Have local necrosis in recurrent lesions, estimated with bleeding risk;
- Unexplained fever > 38.5 ℃, except for tumor fever;
- Treated with ≥ 5 days antibiotics one month before enrollment;
- Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis,nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
- Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
- Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requirestreatment;
- Have known allergy to large molecule protein products or any compound of studytherapy;
- Pregnant or breastfeeding;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervicalcancer, and papillary thyroid carcinoma;
- Any other condition, including mental illness or domestic/social factors, deemed bythe investigator to be likely to interfere with a patient's ability to sign informedconsent, cooperate and participate in the study, or interferes with the interpretationof the results.
Study Design
Total Participants: 40
Study Start date:
April 15, 2019
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Eye and ENT Hospital of Fudan University
Shanghai,
ChinaActive - Recruiting
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