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New treatment option for Nasopharyngeal Carcinoma
Official title Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT04453813
What this study is testing
What is Toripalimab plus concurrent chemo-radiotherapy?
Toripalimab plus concurrent chemo-radiotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
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 concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy 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
- Histologically confirmed recurrent nasopharyngeal carcinoma.
- The recurrence time is more than 12 months from the end of the first course of radiotherapy.
- Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
- people must have a measurable disease by CT or MRI per RECIST 1.1 criteria.
- Karnofsky scale (KPS)≥70.
You likely can't join if
- Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal...
- The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as...
- Has known allergy to large molecule protein products or any compound of study therapy.
- Has known people with other malignant tumors.
- Has any active autoimmune disease or history of autoimmune disease.
- Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
See the full eligibility criteria
- Histologically confirmed recurrent nasopharyngeal carcinoma.
- The recurrence time is more than 12 months from the end of the first course of radiotherapy.
- Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
- people must have a measurable disease by CT or MRI per RECIST 1.1 criteria.
- Karnofsky scale (KPS)≥70.
- Normal bone marrow function.
- Normal liver and kidney function:
- total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- Given written informed consent.
- Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal carotid artery) and rT3 (the tumour is confined in the base wall of the...
- The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as unsuitable for secondary radiotherapy by the researchers.
- Has known allergy to large molecule protein products or any compound of study therapy.
- Has known people with other malignant tumors.
- Has any active autoimmune disease or history of autoimmune disease.
- Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- The laboratory examination value does not meet the relevant standards within 7 days before enrollment
- Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
- Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or 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 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 therapy
- Pregnancy or breast feeding
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shaoguan, Guangdong, China
- Zhongshan, Guangdong, China
- Zhuhai, Guangdong, China
- Wuzhou, Guangxi, 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; Shaoguan, Guangdong, China; Zhongshan, Guangdong, China; Zhuhai, Guangdong, China; Wuzhou, Guangxi, 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.