Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma
Recruiting
Phase 3Interventional Study
Recurrent Nasopharyngeal Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
204 (estimated)
Sponsor
Cancer Hospital of Guangxi Medical University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
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Eligibility Criteria
Inclusion Criteria:
1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 (according to the 8th AJCC edition)
3. Satisfactory performance status: ECOG (Eas…
Inclusion Criteria:
1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 (according to the 8th AJCC edition)
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
6. With normal renal function test ( creatinine clearance ≥60 ml/min)
7. sign an "informed consent form
8. Male and no pregnant female
Exclusion Criteria:
1. Age older than 65, or younger than 18 years old
2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
3. Patients with positive HCV antibody.
4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
5. History of interstitial lung disease
6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
8. Women of child-bearing potential who are pregnant or breastfeeding.
9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
11. HIV positive.
12. Severe, uncontrolled medical conditions and infections.
13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.
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