RecruitingPhase 3NCT04376866

Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

Sponsor

Cancer Hospital of Guangxi Medical University

Enrollment

204 participants

Start Date

Jun 28, 2020

Study Type

INTERVENTIONAL

Conditions

Recurrent Nasopharyngeal Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
With normal renal function test ( creatinine clearance ≥60 ml/min)
sign an "informed consent form
Male and no pregnant female

Exclusion Criteria13

Age older than 65, or younger than 18 years old
Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
Patients with positive HCV antibody.
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.
History of interstitial lung disease
Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
Receive or will receive live vaccine within 30 days prior to signing the informed consent.
Women of child-bearing potential who are pregnant or breastfeeding.
Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
Hypersensitivity to macromolecular protein, or to any component of triplezumab.
HIV positive.
Severe, uncontrolled medical conditions and infections.
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.

Interventions

DRUGToripalimab

anti-PD-1 antibody

Locations(1)

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

View Full Details on ClinicalTrials.gov

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NCT04376866

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