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Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04421469
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Zhejiang Cancer Hospital
Jiangxi Provincial Cancer Hospital
Information provided by (Responsible Party):
Fujian Cancer Hospital

Brief Summary:
This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and tolerability of JS001 and chemotherapy combined with local treatment in patients with multiple metastatic nasopharyngeal carcinoma.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Triprilimab(JS001) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open Multicenter Phase II Clinical Study of Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : April 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Comprehensive treatment
Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment.
Drug: Triprilimab(JS001)
  1. JS001 240mg d1, gemcitabine(1g/m²),d1,8 + nedaplatin (80-100mg/m²),d2,q3w,6cycles.The curative effect was evaluated every 2 cycles.If the therapeutic evaluation was SD,the chemotherapy scheme was changed;
  2. Local treatment of active lesions(including radiotherapy and/or radiofrequency ablation);
  3. JS001 maintenance treatment.

Primary Outcome Measures :
  1. Progression-Free Survival(PFS) [ Time Frame: 2 year ]
    PFS was defined as the time from diagnosis of metastasis to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures :
  1. ORR [ Time Frame: 2 year ]
    Objective response rate

  2. DCR [ Time Frame: 2 year ]
    Disease contral rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases was defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥6months as judged by the Investigator;
  3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
  4. Adequate organ function;
  5. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
  6. Able and willing to provide signed informed consent form, and able to comply with all procedures.
  7. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.

Exclusion Criteria:

  1. Patients with a hypersensitivity to any of the drugs used in our study;
  2. With any active autoimmune disease or history of autoimmune disease;
  3. Clinically significant cardiovascular and cerebrovascular diseases;
  4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
  5. Active systemic infection;
  6. Drug or alcohol abuse;
  7. No or limited capacity for civil conduct;
  8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
  9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy;
  10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and subject requiring hormone therapy during trials.
  11. Pregnancy or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04421469

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Contact: Shaojun Lin, DR 13860603879
Contact: Qiaojuan Guo, DR 15080013157

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China, Fujian
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, China, 350014
Contact: Shaojun Lin, DR    0591-62752225   
Sponsors and Collaborators
Fujian Cancer Hospital
Zhejiang Cancer Hospital
Jiangxi Provincial Cancer Hospital
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Responsible Party: Fujian Cancer Hospital Identifier: NCT04421469    
Other Study ID Numbers: NPC005.1
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases