Solid TumorsPhase 1/2NCT04937842
Microtransplantation for Advanced and Relapsed Solid Tumors
A Phase 1/2 study testing microtransplantation, HLA-mismatched donor peripheral stem cell infusion in people with Solid Tumors, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial summary
In this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- microtransplantation, HLA-mismatched donor peripheral stem cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jun 2025
- 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
- Patients are 18-80 years old, regardless of gender or race;
- Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;
- More than two kinds of tumors are allowed;
- Karnofsky score ≥ 60, ECoG physical status ≤ 2;
- Sensitive to chemotherapy or radiotherapy;
- There are measurable lesions;
- There are suitable hematopoietic stem cell donors
Who cannot join
- have no suitable donor or donor refused
- patient refused to accept donor cells
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Fengtai You'anmen Hospital
Beijing, Beijing Municipality
Yong Da
About this study
Official title: Efficacy and Safety of Radiotherapy or Chemotherapy Combined With Microtransplantation in the Treatment of Advanced and Relapsed Solid Tumors
In this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors.
Read the detailed description
The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.
- Conditions
- Solid Tumors
- Being tested
- microtransplantation, HLA-mismatched donor peripheral stem cell infusion
- Keywords
- microtransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microtransplantation, HLA-mismatched donor peripheral stem cell infusionBiological
Also called DSI
infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
| Study group | Role | What they receive |
|---|---|---|
| MST | Experimental | standard chemotherapy with microtransplantation Receives: Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion |
| CT | No intervention | standard chemotherapy only, without microtransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events
Treatment related mortality
Measured: 1 month
time of hematopoietic recovery
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
Measured: 1 month
Secondary outcomes (1)
overall response rate
(markedly effective + effective) / number of patients × 100%
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jun 2021
- Primary completion31 May 2023 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dayong, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Investigators
- Yong Da, Principal investigator, Department of Medical Oncology, Beijing Fengtai You'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937842
- Sponsor's protocol ID
- MST-ST-01
- Status last verified
- Jun 2021
- First submitted
- 30 May 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Radiotherapy or Chemotherapy Combined With Microtransplantation in the Treatment of Advanced and Relapsed Solid Tumors
- ClinicalTrials.gov ID
- NCT04937842
- Acronym / sponsor ID
- MST-ST-01
- Conditions
- Solid Tumors
- Keywords
- microtransplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Jun 2021 (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.
In this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors.
Detailed description
The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MST | Experimental | Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusionstandard chemotherapy with microtransplantation |
| CT | No intervention | –standard chemotherapy only, without microtransplantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients are 18-80 years old, regardless of gender or race;
- Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;
- More than two kinds of tumors are allowed;
- Karnofsky score ≥ 60, ECoG physical status ≤ 2;
- Sensitive to chemotherapy or radiotherapy;
Key exclusion criteria (2 listed)
- have no suitable donor or donor refused
- patient refused to accept donor cells
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 |
|---|---|---|
| microtransplantation, HLA-mismatched donor peripheral stem cell infusionAlso: DSIinfusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC) | Biological | MST |
Primary outcome
Treatment-Emergent Adverse Events
Time frame: 1 month
Treatment related mortality
time of hematopoietic recovery
Time frame: 1 month
Absolute neutrophil count >500/mcL; Platelets ≥20,000/mcL
1 secondary outcome
overall response rate
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- 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.
Yong Da principal investigator
Department of Medical Oncology, Beijing Fengtai You'anmen Hospital
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 microtransplantation, HLA-mismatched donor peripheral stem cell infusion in people with Solid Tumors, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 7 inclusion and 2 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 24 Jun 2021. 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 Yong Da (8613466665939, 15811031508@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events (time frame: 1 month). 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 24 Jun 2021.