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

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03930498
• Other study ID #: High-risk rNPC-JS001
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Sun Yat-sen University
• Contact: Jingjing Miao, M.D
• Phone: 02087342638
• Email: miaojj1[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrence
• Recurrent Nasopharyngeal Carcinoma

Intervention

Drug:
• PD-1 blocking antibody
Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
• Chemotherapy
Cisplatin and Gemcitabine

Radiation:
• IMRT
IMRT 60-66Gy, 1.8-2.0Gy/f/day

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From date of recruitment to death	2 years
Secondary	Objective response rate	Patient's short-term effect	After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Secondary	Disease control rate	Patient's short-term effect	After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
Secondary	Progression free survival	From date of recruitment to disease progression or death	2 years
Secondary	Adverse effects	Evaluating with CTCAE v5.0	through study completion, an average of 3 months
Secondary	Quality of life: EuroQoL 5 dimension	Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)	through whole study, an average of 2 years

External Links

•   Home Page of Sun Yat-sen University Cancer Center