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

• Status: Not yet recruiting
• Trial end date: 2023-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Collaborators: Jiangxi Provincial Cancer Hospital; Zhejiang Cancer Hospital

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.