Status:
UNKNOWN
Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
Lead Sponsor:
Fujian Cancer Hospital
Collaborating Sponsors:
Zhejiang Cancer Hospital
Jiangxi Provincial Cancer Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 multipl...
Eligibility Criteria
Inclusion
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥6months as judged by the Investigator;
- The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- Adequate organ function;
- Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
- Able and willing to provide signed informed consent form, and able to comply with all procedures.
- The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.
Exclusion
- Patients with a hypersensitivity to any of the drugs used in our study;
- With any active autoimmune disease or history of autoimmune disease;
- Clinically significant cardiovascular and cerebrovascular diseases;
- Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
- Active systemic infection;
- Drug or alcohol abuse;
- No or limited capacity for civil conduct;
- 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;
- 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；
- Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and subject requiring hormone therapy during trials.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04421469
Start Date
June 15 2020
End Date
June 15 2023
Last Update
June 9 2020
Active Locations (1)
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1
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, China, 350014