Colorectal CancerPhase 2NCT04118933
A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer
A Phase 2 study testing JS001 in people with Colorectal Cancer, run by Xu jianmin at 1 site in China.
Trial summary
To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- JS001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2019to 17 Jul 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the study and sign informed consent voluntarily;
- Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;
- Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence;
- At least one measurable lesion (RECIST 1.1);
- Agree to provide tumor tissue samples and Pathology reports related to the specimens;
- Aged 18 to 75 years, gender not limited;
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- Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1; 8. Expected survival ≥3 months;
- Laboratory test values must meet the following standards within 7 days before enrollment;
- Women of reproductive age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use
Who cannot join
- Uncontrolled or symptomatic hypercalcemia;
- Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment;
- central nervous system(CNS) metastases;
- Bone metastases;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling;
- Having a history of idiopathic pulmonary fibrosis, organic pneumonia;
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- Uncontrolled active infection, including but not limited to acute pneumonia;
- Have other malignant tumors at the same time;
- The patient has any active autoimmune diseases or a history of autoimmune diseases;
- Liver diseases of known clinical significance, including active viral viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, fatty liver and hereditary liver diseases.
- Previous use of anti-PD-1 antibody, anti-PD-l1 antibody, anti-PD-l2 antibody or anti-CTLA-4 antibody;
- Patients with active tuberculosis (TB);
- Received systemic immunosuppressive within 4 weeks prior to day 1 of the first cycle;
- Pregnancy test positive;
- Known human immunodeficiency virus (HIV) infection;
- A history of severe allergy, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
- Those who are known to be allergic to biological drugs produced by hamster ovary cells in China, or to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the experimental drugs);
- Patients who have previously received allogeneic stem cells or parenchymal organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Dexiang Zhu, MD, +8613764353275, shzhudx@163.com
About this study
Official title: An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer
To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor.
- Conditions
- Colorectal Cancer
- Being tested
- JS001
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS001Drug
JS001 240mg, Q3W
| Study group | Role | What they receive |
|---|---|---|
| MSI-H advanced colorectal cancer | Experimental | Not described Receives: Drug: JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
The 12 week objective response will be measured according to RECIST v1.1
Measured: 12 Weeks from the drug firstly being taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start17 Jul 2019
- Primary completion17 Jul 2020 (estimated)
- Study completion17 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu jianmin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118933
- Sponsor's protocol ID
- K19406-JS001-ISS-141
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04118933
- Acronym / sponsor ID
- K19406-JS001-ISS-141
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xu jianminUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 17 Jul 2020 (estimated)
- Study completion
- 17 Jul 2021 (estimated)
- First posted
- 8 Oct 2019 (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.
To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSI-H advanced colorectal cancer | Experimental | Drug: JS001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand the study and sign informed consent voluntarily;
- Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;
- Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence;
- At least one measurable lesion (RECIST 1.1);
- Agree to provide tumor tissue samples and Pathology reports related to the specimens;
Key exclusion criteria (18 listed)
- Uncontrolled or symptomatic hypercalcemia;
- Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment;
- central nervous system(CNS) metastases;
- Bone metastases;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling;
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 |
|---|---|---|
| JS001JS001 240mg, Q3W | Drug | MSI-H advanced colorectal cancer |
Primary outcome
objective response rate
Time frame: 12 Weeks from the drug firstly being taken
The 12 week objective response will be measured according to RECIST v1.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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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 JS001 in people with Colorectal Cancer, run by Xu jianmin 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 9 inclusion and 18 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 8 Oct 2019. 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 Jianmin Xu, MD (+8613501984869, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 12 Weeks from the drug firstly being taken). 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 8 Oct 2019.