Malignant AscitesPhase 1/2NCT03230708
Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites
A Phase 1/2 study testing Erythrocytes derived MPs containing MTX and convention drugs in people with Malignant Ascites, run by Hui ting Xu，MD at 1 site in China.
Trial summary
This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- Erythrocytes derived MPs containing MTX and convention drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Feb 2018
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and ≤ 80 years of age
- Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor cells were detected by exfoliative cytology of peritoneal effusion, refractory or recurrent ascites of ovarian cancer were required, other kinds of cancer were not limited
- Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months
- The hematopoietic function of bone marrow was normal without bleeding tendency (INR < 1.5), blood routine examination: HGB ≥ 90 g/L, WBC > 4.0 × 10^9/L (NEU ≥ 1.5 × 10^9/L), PLT ≥ 80 × 10^9/L
- Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN
- Renal function: BUN and Cr ≤ 1.5 ULN, CCr ≥ 50mL/min
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- ECG and blood glucose level were normal
- Patients or family members agreed to participate in the study and signed informed consent
- No other serious heart and lung disease, etc.
Who cannot join
- Pregnant or lactating women
- Allergic constitution and multi-drug allergy
- Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney, liver and other major organs dysfunction or failure, poor blood glucose control, chemotherapy intolerance, combined intestinal obstruction
- Concurrent severe infection
- HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive)
- Cognitive impairment or poor chemotherapy compliance determined by investigator
- Less than 4 weeks from the last clinical trial
- Unsuitable for clinical trials determined by investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hui ting Xu
Wuhan, Hubei, 027
Hui ting Xu, MD, 15307176219 ext. 86, 2891533@qq.com
About this study
Official title: A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites
This study makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.
Read the detailed description
As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.
- Conditions
- Malignant Ascites
- Being tested
- Erythrocytes derived MPs containing MTX, convention drugs
- Keywords
- Microparticles, Erythrocytes, Methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythrocytes derived MPs containing MTXOther
Also called Systemic therapy
General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX
convention drugsDrug
Also called Systemic therapy
according to usage method of drugs
| Study group | Role | What they receive |
|---|---|---|
| Erythrocytes derived MPs containing MTX | Experimental | Suspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses. Receives: Other: Erythrocytes derived MPs containing MTX |
| convention drugs | Active comparator | Chemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions. Receives: Drug: convention drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR, Objective Response Rate
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Measured: From assignment of the first subject to 2 months later after the last participant is recruited.
Secondary outcomes (1)
DCR, Disease Control Rate
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
Measured: From assignment of the first subject to 2 months later after the last participant is recruited.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 May 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui ting Xu，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui ting Xu，MD, Hubei Cancer Hospital
- Investigators
- Yan li Nie, MD, Principal investigator, Hu bei CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230708
- Sponsor's protocol ID
- NP-FS-002
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 26 Jul 2017
- 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 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial Study on Autologous Erythrocytes Derived Microparticles Packaging Methotrexate Peritoneal Perfusion in the Treatment of Malignant Ascites
- ClinicalTrials.gov ID
- NCT03230708
- Acronym / sponsor ID
- NP-FS-002
- Conditions
- Malignant Ascites
- Keywords
- Microparticles, Erythrocytes, Methotrexate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hui ting Xu，MDUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 26 Jul 2017 (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 makes an observation over the objective response rate of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination in the treatment of malignant ascites. All the participants will randomly receive the treatment of autologous erythrocytes derived microparticles packaging methotrexate peritoneal perfusion and systemic therapy combination or convention drugs peritoneal perfusion and systemic therapy combination.
Detailed description
As a drug carrier, erythrocytes have their own advantages, such as high biocompatibility, high immune compatibility, simple structure and easy access. In this study, microparticles released from erythrocytes are used as the carrier of chemotherapy drugs and effectively kill tumor cells in malignant ascites. These microparticles can easily reach the tumor site and bring the drug into tumor cells, which can overcome the two main problems in normal chemotherapy: damage to normal cells and drug resistance of tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythrocytes derived MPs containing MTX | Experimental | Other: Erythrocytes derived MPs containing MTXSuspension of erythrocytes derived MPs containing MTX, qd×6, 6 units MPs a time , Two courses. |
| convention drugs | Active comparator | Drug: convention drugsChemotherapeutic drugs, biologicals or traditional Chinese medicine.Dosage form, dosage, frequency and duration according to respective medicine instructions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 and ≤ 80 years of age
- Histological confirmed gastric cancer, colorectal cancer, or ovarian cancer, tumor cells were detected by exfoliative cytology of peritoneal effusion, refractory or recurrent ascites of ovarian cancer were required, other kinds of cancer were not limited
- Vital signs were stable, Karnofsky ≥ 70, life expectancy of more than 3 months
- The hematopoietic function of bone marrow was normal without bleeding tendency (INR < 1.5), blood routine examination: HGB ≥ 90 g/L, WBC > 4.0 × 10^9/L (NEU ≥ 1.5 × 10^9/L), PLT ≥ 80 × 10^9/L
- Liver function: STB ≤ 1.5 ULN, AST and ALT≤ 2.5 ULN (if the abnormity of liver function was mainly caused by tumor invasion, AST and ALT ≤ 5 ULN), ALP ≤ 1.5 ULN
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Allergic constitution and multi-drug allergy
- Serious heart, lung, liver and kidney dysfunction, decompensated heart, lung, kidney, liver and other major organs dysfunction or failure, poor blood glucose control, chemotherapy intolerance, combined intestinal obstruction
- Concurrent severe infection
- HIV positive, HBsAg and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/mL), chronic hepatitis C blood screening positive (HCV antibody positive)
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 |
|---|---|---|
| Erythrocytes derived MPs containing MTXAlso: Systemic therapyGeneral conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX | Other | Erythrocytes derived MPs containing MTX |
| convention drugsAlso: Systemic therapyaccording to usage method of drugs | Drug | convention drugs |
Primary outcome
ORR, Objective Response Rate
Time frame: From assignment of the first subject to 2 months later after the last participant is recruited.
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
1 secondary outcome
DCR, Disease Control Rate
Time frame: From assignment of the first subject to 2 months later after the last participant is recruited.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: No
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Retlirafusp Alfa Plus SOX and Intraperitoneal Nab-Paclitaxel for Advanced Gastric/GEJ Cancer With Malignant Ascites
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Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites
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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.
Yan li Nie, MD principal investigator
Hu bei CH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Erythrocytes derived MPs containing MTX and convention drugs in people with Malignant Ascites, run by Hui ting Xu，MD 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 8 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 Jul 2017. 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 combined 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.
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 Hui ting Xu (15307176219 ext. 86, 2891533@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR, Objective Response Rate (time frame: From assignment of the first subject to 2 months later after the last participant is recruited.). 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 Jul 2017.