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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Triprilimab(JS001)
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of radiation oncology, Fujian cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comprehensive treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ORR
Objective response rate
DCR
Disease contral rate

Full Information

First Posted
June 5, 2020
Last Updated
June 5, 2020
Sponsor
Fujian Cancer Hospital
Collaborators
Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04421469
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
Collaborators
Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive treatment
Arm Type
Experimental
Arm Description
Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment.
Intervention Type
Drug
Intervention Name(s)
Triprilimab(JS001)
Intervention Description
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; Local treatment of active lesions(including radiotherapy and/or radiofrequency ablation); JS001 maintenance treatment.
Primary Outcome Measure Information:
Title
Progression-Free Survival(PFS)
Description
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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
ORR
Description
Objective response rate
Time Frame
2 year
Title
DCR
Description
Disease contral rate
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaojun Lin, DR
Phone
13860603879
Email
linshaojun@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Qiaojuan Guo, DR
Phone
15080013157
Email
guoqiaojuan@163.com
Facility Information:
Facility Name
Department of radiation oncology, Fujian cancer hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaojun Lin, DR
Phone
0591-62752225
Email
linshaojun@yeah.com

12. IPD Sharing Statement

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

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