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

RecruitingPhase 3Ages 18 Years - 70 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Toripalimab
  • Chemotherapy
  • Intensity modulated radiotherapy
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Where

12 sites
Sun Yat-sen University Cancer Center
Guangzhou, China
Peking University Third Hospital
Beijing, China
Sichuan Cancer Hospital
Chengdu, China
Fujian Province Cancer Hospital
Fuzhou, 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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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