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

NCT ID: NCT04421469

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2023-06-15

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Comprehensive treatment

Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment.

Group Type: EXPERIMENTAL

Triprilimab(JS001)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, China

Countries

China

Central Contacts

Shaojun Lin, DR

Role: CONTACT

linshaojun@yeah.net

13860603879

Qiaojuan Guo, DR

Role: CONTACT

guoqiaojuan@163.com

15080013157

Facility Contacts

Shaojun Lin, DR

Role: primary

linshaojun@yeah.com

0591-62752225

Other Identifiers

NPC005.1

Identifier Type: -

Identifier Source: org_study_id