Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Apr 26, 2028
  • participants needed
    204
  • sponsor
    Cancer Hospital of Guangxi Medical University
Updated on 26 July 2021

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.

Description

Nasopharyngeal carcinoma (NPC) is endemic in southern China, southeast Asia, and northern Africa. According to a survey from the International Agency for Research on Cancer, there were an estimated 129,079 new cases and 72,987 related deaths in 2018. Radiotherapy is the primary treatment option. Due to advances in disease management, diagnostic imaging, radiotherapy technology, and the broader application of systemic therapy, the prognosis of NPC has improved signifificantly.Nevertheless, localregional recurrence will occur in about 10% patients. Because of radiation resistance, the prognosis of re-irradiation is poor for recurrent nasopharyngeal carcinoma.

Hence, there is an urgent need for novel therapies to improve survival and reduce treatment-related toxicity in recurrent NPC patients. Emerging evidence shows that PD-1 antibody is effective for treating recurrent/metastastic NPC patients. This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of neoadjuvant and adjuvant PD-1 antibody Toripalimab combined with concurrent chemoradiotherapy (CCRT) versus CCRT alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.

Details
Condition Recurrent Nasopharyngeal Carcinoma
Treatment Toripalimab
Clinical Study IdentifierNCT04376866
SponsorCancer Hospital of Guangxi Medical University
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
staged as rT3-4N0-1M0rT1-4N2-3M0 according to the 8th AJCC edition
Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
Neutrophil 1.5109 /L and PLT 4109 /L and HGB 90 g/L
With normal liver function test (ALTAST 2.5ULN, TBIL 1.5ULN)
With normal renal function test ( creatinine clearance 60 ml/min)
sign an "informed consent form
Male and no pregnant female

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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