Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
A Single-arm, Open Multicenter Phase II Clinical Study of Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
June 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedJune 9, 2020
June 1, 2020
2.8 years
June 5, 2020
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival(PFS)
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.
2 year
Secondary Outcomes (2)
ORR
2 year
DCR
2 year
Study Arms (1)
Comprehensive treatment
EXPERIMENTALPatients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fujian Cancer Hospitallead
- Zhejiang Cancer Hospitalcollaborator
- Jiangxi Provincial Cancer Hospitalcollaborator
Study Sites (1)
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, 350014, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
June 15, 2020
Primary Completion
April 15, 2023
Study Completion
June 15, 2023
Last Updated
June 9, 2020
Record last verified: 2020-06