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โ† Trials
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Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

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

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.

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

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ค70. 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 โ‰ฅ1000cps/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.
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What it tests

  • Toripalimab
  • salvage surgery
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Where

7 sites
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Nanfang Hospital of Southern Medical University
Guangzhou, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First People's Hospital of Foshan
Guangzhou, China
Zhongshan People's Hospital
Zhongshan, China
The Tenth Affiliated Hospital, Sun Yat-Sen University
Nanchang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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