Clinical trial NCT05340491: Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Official title: Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: locoregional relapse
nasopharyngeal carcinoma
chemoradiotherapy
PD-1 antibody
efficacy
toxicity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: three years
Secondary outcomes:
measure: Failure-free survival
timeFrame: three years
measure: Objective response rate through study completion, an average of nine months
timeFrame: through study completion, an average of nine months
measure: Disease control rate through study completion, an average of nine months
timeFrame: through study completion, an average of nine months
measure: Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years
timeFrame: up to three-year follow-up
measure: Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)
timeFrame: through study completion, an average of nine months
measure: Late toxicity
timeFrame: three years
measure: Quality of life through study completion, up to 3 years
timeFrame: up to three-year follow-up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Xi'an
country: China
facility: Xijing Hospital
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: