Advanced Malignant TumorsPhase 2NCT05354076
Study on the Correlation Between Immunoglobulin and Liposomal Doxorubicin in Vivo
A Phase 2 study testing doxorubicin hydrochloride liposome injection in people with Advanced Malignant Tumors, run by Fudan University at 1 site in China.
Trial summary
To study the correlation between the content of natural IgM in patients' blood samples and liposomal doxorubicin for clinical use, and to explore the possibility of using natural IgM content to guide clinical accurate medication. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- doxorubicin hydrochloride liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2000to 1 Nov 2022
- 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 aged 18-70 years (including cutoff value), regardless of gender.
- According to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy.
- Eastern Cooperative Oncology Group Performance Status of 0-1.
- Life expectancy ≥ 3 months.
- Adequate function of major organs meets the following requirements :
- Neutrophils ≥ 1.5×10^9/L
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- Platelets ≥ 75×10^9/L
- Hemoglobin ≥ 90g/L
- Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
- ALT and AST ≤ 2.5 × ULN, Subjects with liver metastasis require TBIL ≤ 1.5 × ULN, ALT and AST ≤ 5 × ULN。
- BUN and Cr ≤ 1.5 × ULN, Or creatinine clearance (CCR) ≥ 50 ml / min.
- International normalized ratio(INR)≤1.5 × ULN，activated partial thromboplastin time(APTT) ≤ 1.5 × ULN
- Women should agree to use effective contraceptives (such as intrauterine device [IUD], contraceptive or condom) during the study period and within 6 months after the end of the study; serum pregnancy test is negative within 7 days before the study and must be non lactating subjects; men should be the same subjects who intend to use contraceptives during the study period and within 6 months after the end of the study period.
- Patients volunteered to participate in the study, signed informed consent, and were able to follow the blood sampling, visit and related procedures specified in the trial.
Who cannot join
- Received systemic therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments within 4 weeks before enrollment; according to the judgment of the researcher, the cleaning period can be appropriately shortened or extended. For example, for endocrine drugs, in order to avoid making patients wait too long, the cleaning period can be appropriately shortened to 2 weeks.
- Those weighing less than 40 kg.
- Previously received any liposomal doxorubicin analogues treatment.
- Patients with a history of allergy to liposomes or adriamycin.
- Have a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (ventricular arrhythmia requiring clinical intervention, degree II ~ III atrioventricular block, etc.), cardiac infarction, history of coronary artery bridging surgery, heart failure, NYHA grade II or above, left ventricular ejection fraction (LVEF) ≤ 50%, male QTCF > 450msec or female QTCF > 470msec, etc.
- Patients with active infection (NCI CTC AE v5.0 ≥ grade 2).
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- Patients have a history of autoimmune diseases and immune defects, including HIV test positive, or have other acquired and congenital immune defects, or have a history of organ transplantation and need to take corticosteroids routinely.
- Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer detection is more than 1. ×103 IU / ml; If HBsAg is positive and HBV-DNA in peripheral blood is less than 1 × 103IU/mL, if the researchers believe that the chronic hepatitis B is stable and does not increase the risk of the subjects, the subjects are eligible to be selected.
- Anti hepatitis C virus antibody and anti treponema pallidum specific antibody were positive.
- Have a clear history of neurological or mental disorders, including epilepsy or dementia.
- Patients with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence indicating that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, patients with asymptomatic brain metastasis, or stable clinical symptoms without steroid hormone and other treatment for brain metastasis for ≥ 28 days can be enrolled.
- According to the judgment of the investigator, there are other accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study.
- Pregnant or lactating female subjects.
- Patients considered unsuitable by the investigator to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, M.D., 021-54561523, syner2000@163.com
About this study
To study the correlation between the content of natural IgM in patients' blood samples and liposomal doxorubicin for clinical use, and to explore the possibility of using natural IgM content to guide clinical accurate medication.
- Conditions
- Advanced Malignant Tumors
- Being tested
- doxorubicin hydrochloride liposome injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin hydrochloride liposome injectionDrug
According to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy.(For breast cancer patients: liposomal doxorubicin 35mg/m2 q3w)
| Study group | Role | What they receive |
|---|---|---|
| liposomal doxorubicin | Experimental | According to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy. Receives: Drug: doxorubicin hydrochloride liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The content of natural IgM in patients' blood samples
IgM regulates the performance of liposomes by regulating the efficiency of liposomes activating complement in vivo. Among many immunoglobulins, IgM rather than IgG is the key plasma protein affecting the efficiency of liposomes activating complement.The content of IgM in serum were detected by ELISA
Measured: 6 weeks
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Mar 2000
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354076
- Sponsor's protocol ID
- 2019-liposomal doxorubicin-01
- Status last verified
- Apr 2022
- First submitted
- 22 Dec 2021
- Last updated
- 29 Apr 2022
- 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 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Immunoglobulin and Liposomal Doxorubicin in Vivo
- ClinicalTrials.gov ID
- NCT05354076
- Acronym / sponsor ID
- 2019-liposomal doxorubicin-01
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2000 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 29 Apr 2022 (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 study the correlation between the content of natural IgM in patients' blood samples and liposomal doxorubicin for clinical use, and to explore the possibility of using natural IgM content to guide clinical accurate medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liposomal doxorubicin | Experimental | Drug: doxorubicin hydrochloride liposome injectionAccording to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients aged 18-70 years (including cutoff value), regardless of gender.
- According to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy.
- Eastern Cooperative Oncology Group Performance Status of 0-1.
- Life expectancy ≥ 3 months.
- Adequate function of major organs meets the following requirements :
Key exclusion criteria (14 listed)
- Received systemic therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments within 4 weeks before enrollment; according to the judgment of the researcher, the cleaning period can be appropriately shortened or extended. For example, for endocrine drugs, in order to avoid making patients wait too long, the cleaning period can be appropriately shortened to 2 weeks.
- Those weighing less than 40 kg.
- Previously received any liposomal doxorubicin analogues treatment.
- Patients with a history of allergy to liposomes or adriamycin.
- Have a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (ventricular arrhythmia requiring clinical intervention, degree II ~ III atrioventricular block, etc.), cardiac infarction, history of coronary artery bridging surgery, heart failure, NYHA grade II or above, left ventricular ejection fraction (LVEF) ≤ 50%, male QTCF > 450msec or female QTCF > 470msec, etc.
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 |
|---|---|---|
| doxorubicin hydrochloride liposome injectionAccording to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy.(For breast cancer patients: liposomal doxorubicin 35mg/m2 q3w) | Drug | liposomal doxorubicin |
Primary outcome
The content of natural IgM in patients' blood samples
Time frame: 6 weeks
IgM regulates the performance of liposomes by regulating the efficiency of liposomes activating complement in vivo. Among many immunoglobulins, IgM rather than IgG is the key plasma protein affecting the efficiency of liposomes activating complement.The content of IgM in serum were detected by ELISA
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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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 doxorubicin hydrochloride liposome injection in people with Advanced Malignant Tumors, run by Fudan University 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 14 inclusion and 14 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 29 Apr 2022. 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 Jian Zhang, MD,PhD (021-64175590 ext. 73546, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The content of natural IgM in patients' blood samples (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 29 Apr 2022.