Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Feb 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called Toripalimab, which helps the immune system fight cancer, to surgery can improve outcomes for patients with a specific type of cancer called nasopharyngeal carcinoma that has come back after treatment. The goal is to see if this combination can reduce the chances of the cancer returning and help patients live longer compared to those who only receive surgery.

To be eligible for this trial, participants should have had their cancer come back at least six months after finishing radiation therapy and must have tumors that can still be surgically removed. Patients with certain health conditions or who are currently undergoing other treatments may not qualify. If you join the study, you will receive either the Toripalimab treatment along with surgery or just surgery, and you will be monitored closely throughout the process to track your health and the effects of the treatment. This trial is currently recruiting participants of all genders, aged between 18 and 75.

Gender

ALL

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.