Using Toripalimab 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 phase 3, multicentre, randomised controlled trial investigates the effectiveness and toxicity of the PD-1 antibody Toripalimab when combined with concurrent cisplatin chemoradiotherapy in patients with locoregionally recurrent nasopharyngeal carcinoma. The study aims to improve survival rates and reduce treatment-related toxicity in patients who have experienced local-regional recurrence of this cancer. Participants will be randomly assigned to receive either the combination treatment or cisplatin chemoradiotherapy alone. The trial is particularly focused on patients with specific staging and performance status criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
6. With normal renal function test ( creatinine clearance ≥60 ml/min)
7. sign an "informed consent form
8. Male and no pregnant female

Exclusion Criteria:

1. Age older than 65, or younger than 18 years old
2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
3. Patients with positive HCV antibody.
4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
5. History of interstitial lung disease
6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
8. Women of child-bearing potential who are pregnant or breastfeeding.
9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
11. HIV positive.
12. Severe, uncontrolled medical conditions and infections.
13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Where it's running

• Guangxi Medical University Cancer Hospital
  Nanning, Guangxi, China Recruiting

Study contacts

• Principal investigator: Song Qu, PhD — Principal Investigator
• Study coordinator: Song Qu, PhD
• Email: daisyqs2002@163.com
• Phone: 86-13607887386

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• SABR with Axitinib and Toripalimab for oligometastatic kidney cancer

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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.