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Clinical Trials in China / NCT04778956
Recruiting Phase 3

Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

NCT04778956 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 3
Started
2021-03-03
Last updated
2021-03-04

Condition(s) studied

Nasopharyngeal CarcinomaPD-1Surgery

Investigational drug(s) / intervention(s)

Toripalimabsalvage surgery

Toripalimab: Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

salvage surgery: Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
The First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong Not Yet Recruiting
Nanfang Hospital of Southern Medical University Guangzhou Guangdong Not Yet Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
The First People's Hospital of Foshan Guangzhou Guangdong Not Yet Recruiting
Zhongshan People's Hospital Zhongshan Guangdong Not Yet Recruiting
The Tenth Affiliated Hospital, Sun Yat-Sen University Nanchang Jiangxi Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04778956 on ClinicalTrials.gov ↗ ← All trials in China