Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase

Active, not recruiting

Phase 2

Conditions

Recurrent Nasopharyngeal Carcinoma

Treatments

Drug: PD-1 blocking antibody

Drug: Chemotherapy

Radiation: IMRT

Study type

Interventional

Funder types

Other

Identifiers

NCT03930498

High-risk rNPC-JS001

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.