PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial

Sun Yat-sen University1 site in 1 country68 target enrollmentMarch 12, 2020

ConditionsRecurrent Nasopharyngeal Carcinoma

InterventionsPD-1 blocking antibody Chemotherapy IMRT

DrugsPD-1 blocking antibody Chemotherapy

Overview

Phase: Phase 2
Intervention: PD-1 blocking antibody
Conditions: Recurrent Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 68
Locations: 1
Primary Endpoint: Overall survival
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 12, 2020

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Zhao Chong

Prof.

Sun Yat-sen University

Eligibility 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;

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;

Arms & Interventions

PD-1 antibody plus chemoradiotherapy

Intervention: PD-1 blocking antibody

PD-1 antibody plus chemoradiotherapy

Intervention: Chemotherapy

PD-1 antibody plus chemoradiotherapy

Intervention: IMRT

Outcomes

Primary Outcomes

Overall survival

Time Frame: 2 years

From date of recruitment to death

Secondary Outcomes

Objective response rate(After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days))
Progression free survival(2 years)
Disease control rate(After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days))
Adverse effects(through study completion, an average of 3 months)
Quality of life: EuroQoL 5 dimension(through whole study, an average of 2 years)