NCT04778956 Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
| NCT ID | NCT04778956 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2021-03-03 |
| Primary Completion | 2025-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 218 participants in total. It began in 2021-03-03 with a primary completion date of 2025-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Ming-Yuan Chen, MD, PhD
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT04778956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04778956 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 218 participants.
Is NCT04778956 currently recruiting?
Yes, NCT04778956 is actively recruiting participants. Contact the research team at chmingy@mail.sysu.edu.cn for enrollment information.
Where is the NCT04778956 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Guangzhou, China and 3 additional locations.
Who is sponsoring the NCT04778956 clinical trial?
NCT04778956 is sponsored by Sun Yat-sen University. The principal investigator is Ming-Yuan Chen, MD, PhD at Sun Yat-sen University. The trial plans to enroll 218 participants.