Combining Toripalimab with Surgery 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 clinical trial investigates the effectiveness of adding Toripalimab, a PD-1 antibody, to salvage surgery for patients with resectable locally recurrent nasopharyngeal carcinoma. Participants are randomly assigned to receive either the combination of Toripalimab and surgery or surgery alone. The study aims to compare the disease progression rates and survival outcomes between the two groups. It is conducted across multiple centers to ensure a diverse patient population and robust data collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The recurrence time is more than 6 months from the end of radiotherapy.
2. Histologically confirmed recurrent nasopharyngeal carcinoma.
3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
4. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
5. Given written informed consent.

Exclusion Criteria:

1. Karnofsky Performance Status (KPS) ≤70.
2. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
3. Has known subjects with other malignant tumors.
4. Has participated in other drug trials within 3 months of planned start of study treatment.
5. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
6. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
8. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
9. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
10. Has received a live vaccine within 4 weeks of planned start of study treatment.
11. Pregnancy or breast feeding.
12. Cannot complete regular follow-up.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital, Sun Yat-Sen University
  Guangzhou, Guangdong, China Not yet recruiting
• Nanfang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• The Fifth Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• The First People's Hospital of Foshan
  Guangzhou, Guangdong, China Not yet recruiting
• Zhongshan People's Hospital
  Zhongshan, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Ming-Yuan Chen, MD, PhD — Sun Yat-sen University
• Study coordinator: Ming-Yuan Chen, MD, PhD
• Email: chmingy@mail.sysu.edu.cn
• Phone: 86-20-87343624

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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.