Combining chemoradiotherapy with an anti-PD1 treatment for recurrent nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, randomized, controlled phase III trial aims to evaluate the efficacy and toxicity of the anti-PD-1 antibody, Toripalimab, when combined with chemoradiotherapy compared to chemoradiotherapy alone in patients with recurrent nasopharyngeal carcinoma. Eligible participants are those who have experienced local or regional recurrence after at least one year of radical treatment and are not suitable for surgery. The study will assess both the effectiveness of the treatment combination and any associated side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, China Recruiting
• Jiangxi Cancer Hospital
  Nanchang, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, China Recruiting

Study contacts

• Principal investigator: Chong Zhao, MD PhD — Sun Yat-Sen University Cancer Center
• Study coordinator: Jingjing Miao, PhD
• Email: miaojj@sysucc.org.cn
• Phone: +8613631355201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.