Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340491
• Other study ID #: B2022-111-01
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: August 2022
• Source: Sun Yat-sen University
• Contact: Jingjing Miao, PhD
• Phone: +8613631355201
• Email: miaojj[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined 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 with or without regional recurrence after =1 year of radical treatment;
• Not suitable for surgery;
• Histologic diagnosis of NPC (WHO II/III);
• TNM stage rII-IVa (AJCC/UICC 8th);
• ECOG 0-1 point;
• No treatment to rNPC prior, 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:

• 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 =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

Intervention

Drug:
• Toripalimab
240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT
• Chemotherapy
Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

Radiation:
• Intensity modulated radiotherapy
total 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	Defined as the time from date of recruitment to death from any cause.	three years
Secondary	Failure-free survival	Defined as the time from date of recruitment to documented relapse or death from any cause.	three years
Secondary	Objective response rate through study completion, an average of nine months	The rate of patients get CR or PR after treatment	through study completion, an average of nine months
Secondary	Disease control rate through study completion, an average of nine months	The rate of patients get CR or PR or SD after treatment	through study completion, an average of nine months
Secondary	Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years	Incidence of nasopharyngeal necrosis and hemorrhage after receiving treatment	up to three-year follow-up
Secondary	Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)	Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0) for chemotherapy and immunotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.	through study completion, an average of nine months
Secondary	Late toxicity	Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.	three years
Secondary	Quality of life through study completion, up to 3 years	Evaluated with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L).	up to three-year follow-up

External Links

•   Home Page of Sun Yat-sen University Cancer Center