Gastrointestinal CancerPhase 1NCT03474861
Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Gastrointestinal Cancer
A Phase 1 study testing anticancer medication A01; immune cells IC01 in people with Gastrointestinal Cancer, run by Hangzhou Converd Co., Ltd..
Trial summary
This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- anticancer medication A01; immune cells IC01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2019
- Phase
- Phase 1
- 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
- Signed informed consent form must be obtained prior to any research procedures;
- Age: 18 Years to 70 Years;
- The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently;
- Histologically confirmed diagnosis of gastrointestinal cancer;
- Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
- Karnofsky Performance Status (KPS) score ≥ 70
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- Expected survival ≥ 3 months
- Adequate organ function defined as: ANC≥3.5×10^9/L, PLT≥50×10^9/L, ALB≥25g/L, AST≤2.5×ULN, ALT≤2.5×ULN, TBIL≤1.5×ULN
- If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.
Who cannot join
- Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
- Patients who have not recovered from adverse reactions related to above-mentioned procedures;
- Patients with two types of primary solid tumors;
- Patients with brain metastases or bone metastases;
- Patients with poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment;
- Patients with other serious organic diseases or mental disorders;
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- Patients with systemic or active infection;
- Patients with positive HIV test result;
- Patients who have received an organ transplant;
- Patients who are breastfeeding or pregnant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Combination Study to Evaluate the Safety and Efficacy of an Anticancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Gastrointestinal Cancer
This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.
- Conditions
- Gastrointestinal Cancer
- Being tested
- anticancer medication A01; immune cells IC01
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticancer medication A01; immune cells IC01Biological
The administration of the anticancer medication A01 and immune cells IC01 will be performed in The Second Hospital of Jiaxing, Zhejiang, China.
The subjects will be observed for any side effects during this time and all the adverse events will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | The subjects will be given combination therapy which consists of an anticancer medication (A01) and immune cells (IC01). Receives: Biological: anticancer medication A01; immune cells IC01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.
Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.
Measured: Day 0 to 4 months after the end of the trial
Secondary outcomes (1)
Tumor Response of the treatment in patients with advanced gastrointestinal cancer.
Response Evaluation Criteria in Solid Tumors (RECIST) from the NCI will be used for assessment of radiographic response.
Measured: Before treatment and Day 28 to 4 months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Converd Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Jia Xing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474861
- Sponsor's protocol ID
- CVD20180401002
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination Study to Evaluate the Safety and Efficacy of an Anticancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT03474861
- Acronym / sponsor ID
- CVD20180401002
- Conditions
- Gastrointestinal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hangzhou Converd Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Jia Xing
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 23 Mar 2018 (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 is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Biological: anticancer medication A01; immune cells IC01The subjects will be given combination therapy which consists of an anticancer medication (A01) and immune cells (IC01). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent form must be obtained prior to any research procedures;
- Age: 18 Years to 70 Years;
- The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently;
- Histologically confirmed diagnosis of gastrointestinal cancer;
- Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
Key exclusion criteria (10 listed)
- Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
- Patients who have not recovered from adverse reactions related to above-mentioned procedures;
- Patients with two types of primary solid tumors;
- Patients with brain metastases or bone metastases;
- Patients with poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment;
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 |
|---|---|---|
| anticancer medication A01; immune cells IC01The administration of the anticancer medication A01 and immune cells IC01 will be performed in The Second Hospital of Jiaxing, Zhejiang, China. The subjects will be observed for any side effects during this time and all the adverse events will be recorded. | Biological | Combination therapy |
Primary outcome
The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.
Time frame: Day 0 to 4 months after the end of the trial
Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.
1 secondary outcome
Tumor Response of the treatment in patients with advanced gastrointestinal cancer.
Time frame: Before treatment and Day 28 to 4 months after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anticancer medication A01; immune cells IC01 in people with Gastrointestinal Cancer, run by Hangzhou Converd Co., Ltd..
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 10 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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Lin Chen, PhD (+86 18005817715, chenlin@converd.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed. (time frame: Day 0 to 4 months after the end of the trial). 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 26 Mar 2018.