PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03907826
• Other study ID #: rNPC-JS001
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2020
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Jingjing Miao
• Phone: 02087342638
• Email: miaojingjing90[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 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;

• No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;

• No contraindications to immunotherapy or radiotherapy;

• 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:

• Treated with anti-tumor Chinese medicine treatment;

• 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 =10E4copiers/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 240mg, D1, every 3 weeks per cycle
• GP
Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	Sichuan Cancer Hospital	Chengdu
China	Fujian Province Cancer Hospital	Fuzhou
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Guizhou Cancer Hospital	Guiyang
China	Zhejiang Cancer Hospital	Hangzhou
China	Jiangxi Cancer Hospital	Nanchang
China	The First Affiliated Hospital of Guangxi Medical University	Nanning
China	Fudan University Shanghai Cancer Center	Shanghai
China	Zhongnan Hospital of Wuhan University	Wuhan
China	Xijing Hospital	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen

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 randomisation to death	3 years
Secondary	Progression free survival	From date of randomisation to disease progression	3 years
Secondary	Short-term effects	Patient's objective response rate	through study completion, an average of 2 months
Secondary	Rate of patients with acute toxicities	Evaluating with CTCAE v5.0	through study completion, an average of 2 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 3 years

External Links

•   Home Page of Sun Yat-sen University Cancer Center