Clinical trial NCT04421469: Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
Official title: A Single-arm, Open Multicenter Phase II Clinical Study of Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Zhejiang Cancer Hospital
name: Jiangxi Provincial Cancer Hospital
First posted: 2020-06-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival(PFS)
timeFrame: 2 year
Secondary outcomes:
measure: ORR
timeFrame: 2 year
measure: DCR
timeFrame: 2 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of radiation oncology, Fujian cancer hospital
state: Fujian
Study officials:
References: