- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472352
Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Solid Tumors
March 20, 2018 updated by: Hangzhou Converd Co., Ltd.
A Combination Study to Evaluate the Safety and Efficacy of an Anti-cancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Solid Tumors
This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) with immune cells (IC01) in subjects with advanced solid tumors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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 (100-200 ml) for the treatment, and who signs the informed consent form independently;
- Histologically confirmed diagnosis of solid tumors;
- Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
- KPS > 60 points;
- expected survival > 6 months;
- Adequate organ function defined as: ANC≥1.0×10^9/L, PLT≥50×10^9/L, ALB≥25g/L;
- If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.
Exclusion Criteria:
- 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 ClassⅡ or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on the treatment;
- Patients with other serious organic diseases or mental disorders;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
The subjects will be given an anticancer medication (A01) and immune cells (IC01).
|
The administration of A01 and IC01 will be performed in the Second People's Hospital of Yibin, Sichuan, China.
The subjects will be observed for any side effects during this time and all the adverse events will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 study
|
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.
|
Day 0 to 4 months after the end of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response of the treatment in patients with advanced solid tumors.
Time Frame: Before treatment and Day 28 to 4 months after the end of the treatment
|
Response Evaluation Criteria in Solid Tumors (RECIST) from the NCI will be used for assessment of radiographic response.
|
Before treatment and Day 28 to 4 months after the end of the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2018
Primary Completion (Anticipated)
April 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
March 7, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (Actual)
March 21, 2018
Study Record Updates
Last Update Posted (Actual)
March 21, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVD20180401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
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NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
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Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
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Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
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Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
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Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
Clinical Trials on An anticancer medication (A01) and immune cells (IC01)
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Hangzhou Converd Co., Ltd.The Second Hospital of Jia XingUnknown