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Compares treatment options for Nasopharyngeal Carcinoma
Official title Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT04778956
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
Also referred to as PD-1 antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The recurrence time is more than 6 months from the end of radiotherapy.
- Histologically confirmed recurrent nasopharyngeal carcinoma.
- Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal...
- Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery...
- Given written informed consent.
You likely can't join if
- Karnofsky Performance Status (KPS) ≤70.
- Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- Has known people with other malignant tumors.
- Has participated in other drug trials within 3 months of planned start of study treatment.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with...
See the full eligibility criteria
- The recurrence time is more than 6 months from the end of radiotherapy.
- Histologically confirmed recurrent nasopharyngeal carcinoma.
- 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...
- 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)
- Given written informed consent.
- Karnofsky Performance Status (KPS) ≤70.
- Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- Has known people with other malignant tumors.
- Has participated in other drug trials within 3 months of planned start of study treatment.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
- 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...
- 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.
- Has received a live vaccine within 4 weeks of planned start of study treatment.
- Pregnancy or breast feeding.
- Cannot complete regular follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhongshan, Guangdong, China; Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.