Nasopharyngeal CarcinomaPhase 2NCT04421469
Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
A Phase 2 study testing Triprilimab(JS001) in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Triprilimab(JS001)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 15 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, 350014
Shaojun Lin, DR, 0591-62752225, linshaojun@yeah.com
About this study
Official title: A Single-arm, Open Multicenter Phase II Clinical Study of Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
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
- Being tested
- Triprilimab(JS001)
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triprilimab(JS001)Drug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive treatment | Experimental | Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment. Receives: Drug: Triprilimab(JS001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Secondary outcomes (2)
ORR
Objective response rate
Measured: 2 year
DCR
Disease contral rate
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Jun 2020 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421469
- Sponsor's protocol ID
- NPC005.1
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open Multicenter Phase II Clinical Study of Triprilimab(JS001) and Chemotherapy Combined With Local Treatment for Multiple Metastatic NPC
- ClinicalTrials.gov ID
- NCT04421469
- Acronym / sponsor ID
- NPC005.1
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Collaborators
- Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive treatment | Experimental | Drug: Triprilimab(JS001)Patients with multiple metastatic NPC were given Triprilimab(JS001) and chemotherapy combined with local treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Comprehensive treatment |
Primary outcome
Progression-Free Survival(PFS)
Time frame: 2 year
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 secondary outcomes
ORR
Time frame: 2 year
DCR
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triprilimab(JS001) in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaojun Lin, DR (13860603879, linshaojun@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival(PFS) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.