Overview
Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma
Status:
Recruiting
Recruiting
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-sen UniversityTreatments:
Antibodies
Antibodies, Blocking
Immunoglobulins
Criteria
Inclusion Criteria:- Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical
treatment;
- Not suitable for surgery;
- Newly histologic diagnosis of NPC (WHO II/III);
- Clinical stage rII-IVa (AJCC/UICC 8th);
- ECOG 0-1 point;
- PRANCIS score > 252 points;
- No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- 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 written
informed consent.
Exclusion Criteria:
- Have recurrence with local necrosis;
- Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- 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 previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1
pathway;
- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial
-infarction within 1 year, or clinically meaningful arrhythmia that requires
treatment;
- Have known allergy to large molecule protein products or any compound of study
therapy;
- Pregnant or breastfeeding;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical
cancer, and papillary thyroid carcinoma;
- Have received a live vaccine within 30 days of planned start of study therapy Has
psychiatric drug or substance abuse disorders that would interfere with cooperation
with the requirements of the trial;
- Any other condition, including mental illness or domestic/social factors, deemed by
the investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interferes with the interpretation
of the results.