Comparing Chemotherapy With/Without Toripalimab For Primary Metastatic Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    126
  • sponsor
    Fudan University
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Updated on 4 August 2021
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renal function
carcinoma
capecitabine
gemcitabine
chemotherapy regimen
toripalimab
immunomodulator
renal function test
intensity-modulated radiation therapy
nasopharyngeal carcinoma
metastatic nasopharyngeal carcinoma

Summary

The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.

Description

About 4-10% of patients with nasopharyngeal carcinoma (NPC) have metastatic disease at diagnosis. The treatment recommendation of primary metastatic NPC is systemic chemotherapy. However, the optimal regimen is yet to determine due to lack of prospective randomized trial for this unique group of patients. Generally, GP regimen is used as the first-line treatment of primary metastatic NPC. The aim of this study is to compare the efficacy of Toripalimab Combined with GP Regimen Chemotherapy Versus GP Regimen Chemotherapy for Primary Metastatic NPC.

Details
Condition Vulvar Dysplasia and Carcinoma, Carcinoma, Advanced Malignancies, Nasopharyngeal Cancer, nasopharyngeal carcinoma
Treatment Toripalimab, IMRT to the nasopharynx and neck, Gemcitabine and Cisplatin Chemotherapy, Gemcitabine and Cisplatin Chemotherapy, Adjuvant chemotherapy with Capecitabine
Clinical Study IdentifierNCT04517214
SponsorFudan University
Last Modified on4 August 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Sign an informed consent
Age older than 18 years old and younger than 70 years old
Patients with newly histologically confirmed primary metastatic nasopharyngeal carcinoma
At least one metastatic site that fulfills the criteria of "Evaluable Disease" per RECIST 1.1 Criteria
Anticipated overall survival more than 3 months
Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1
No primary treatment of radiation, surgery, chemotherapy, targeted therapy and immune therapy post diagnosis of NPC
Neutrophil 1.5109 /L and PLT 100109 /L and HGB 90 g/L
With normal liver function test (ALTAST 3ULN, TBIL 1.5ULN, Albumin2.8g/dL )
With normal renal function test (Creatinine 1.5 ULN and creatinine clearance 60 ml/min)
HBV DNA<500 IU/mLor 2500 copies/mLand HCV RNA negative
Male and no pregnant female, able to adapt birth control methods during treatment

Exclusion Criteria

Hypersensitivity to Toripalimab, Gemcitabine, Cisplatin and Capecitabine
Symptomatic spinal cord compression, or high-risk to develop pathological fracture that requires urgent surgery or radiation
Necrotic disease, high-risk of massive nasal bleeding
Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years
Receive vaccine or live vaccine within 30 days prior to signing the informed consent
Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent
Severe, uncontrolled medical conditions and infections
Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy; vitiligo or inactive asthma who don't need systemic therapy can recruit
History of interstitial lung disease
HIV positive
Hepatitis B surface antigen (HBsAg) positive and HBV-DNA 500IU/ml, or 2500cps/ml; Positive HCV RNA
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
Women of child-bearing potential who are pregnant or breastfeeding
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renal function
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chemotherapy regimen
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immunomodulator
renal function test
intensity-modulated radiation therapy
nasopharyngeal carcinoma
metastatic nasopharyngeal carcinoma

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