Combining PD-1 antibody with chemoradiotherapy 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, randomized controlled phase III clinical trial aims to evaluate the efficacy and adverse effects of a PD-1 antibody in combination with chemoradiotherapy compared to chemoradiotherapy alone in patients with recurrent nasopharyngeal carcinoma. Participants will be monitored for treatment outcomes and side effects to determine the potential benefits of this combined approach. The study includes patients who have experienced local or regional recurrence after radical treatment and are not suitable for surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Guizhou Cancer Hospital
  Guiyang, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, China Recruiting
• Xijing Hospital
  Xi'an, China Recruiting
• Peking University Third Hospital
  Beijing, China Not yet recruiting

Study contacts

• Principal investigator: Chong Zhao — Sun Yat-Sen University Cancer Center
• Study coordinator: Jingjing Miao
• Email: miaojingjing90@163.com
• Phone: 02087342638

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Adding a new drug to immunotherapy for advanced nasopharyngeal cancer

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  Recruiting at 83 sites Phase 2 National Cancer Institute (NCI) · Dublin, California and 94 other locations · NCT06029270

• Low-temperature plasma radiofrequency ablation versus high-frequency electrocautery resection for localized recurrent nasopharyngeal carcinoma

  This trial will see if low-temperature plasma radiofrequency ablation works better than high-frequency electrocautery resection for adults with localized recurrent nasopharyngeal carcinoma.

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• Using Toripalimab with Chemoradiotherapy for Recurrent Nasopharyngeal Carcinoma

  This study is testing if adding a new drug called Toripalimab to standard chemotherapy and radiation can help people with recurrent nasopharyngeal cancer live longer and feel better during treatment.

  Recruiting Phase 3 Cancer Hospital of Guangxi Medical University · Nanning, Guangxi · NCT04376866

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.