Myelodysplastic SyndromesPhase 1/2NCT05584761
Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML
A Phase 1/2 study testing unrelated umbilical cord blood in people with Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia-2, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia-2, Secondary Acute Myeloid Leukemia
- What is being tested?
- unrelated umbilical cord blood
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- BCR/ABL positive chronic myelogenous leukemia, primary myelofibrosis, polycythemia vera and essential thrombocythemia;
- Low risk myelodysplastic syndromes according to IPSS or revised IPSS prognostic risk categories;
- Acute promyelocytic leukemia, myeloid sarcoma, or accelerated or blastic phase of chronic myelogenous leukemia;
- Allergic to any of the mentioned agent in the study protocol;
- Pregnant or lactating women, or patients during reproductive stage but not willing to take contraception methods;
- With obvious dysfunction of liver or kidney, not fulfilling the inclusion criteria;
Show all 18Show fewer
- With organic heart disease, which causes clinical symptoms or cardiac dysfunction ( ≥ Class 2 cardiac disease as defined by the New York Heart Association Functional Classification, NYHA );
- At the same time suffering from other malignant tumors, with the exception of the following: (1) malignancy treated with curative intent and with no evidence of active disease present for more than 5 years prior to screening; (2) adequately treated lentigo maligna melanoma without current evidence of disease or adequately-controlled non-melanomatous skin cancer (even if less than 3 years prior to screening); (3) adequately treated cervical carcinoma in situ without current evidence of disease (even if less than 3 years prior to screening);
- Known history of human immunodeficiency virus (HIV) or syphilis, or active infection with Hepatitis B (HBV-DNA positive) or Hepatitis C;
- Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or history of myocardial infarction within 6 months prior to first dose with study drug, or any Class 3 or 4 cardiac disease as defined by NYHA;
- Any concurrent medical condition or disease (eg, active systemic infection) that may interfere with the research procedure or outcome, or that the subject may have a risk to participate in the study;
- Cannot understand or follow the study protocol;
- Patients under 12 years old or over 80 years old;
- Received major surgery within 4 weeks prior to randomization;
- Participated in other clinical researches at the same time one month before enrollment;
- Cannot matching suitable cord blood stem cell;
- Addicted to illegal drugs;
- Have mental disorders or cognitive disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Fei Huang, MD, +8615950523133, huangfei0815@126.com
About this study
Official title: A Perspective, Multicenter, Open-label and Observational Trial for Unrelated Umbilical Cord Blood Stem Cell Microtransplantation Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and Secondary AML.
This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). The study protocol involved unrelated umbilical cord blood stem cell combined with azacitidine based treatment, which including azacitidine alone and azacitidine plus a targeted agent or chemotherapy agent.
Read the detailed description
This is a perspective, multicenter, open-label and observational trial for unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine based treatment for advanced MDS,CMML-2 and secondary AML. The study protocol is AZA /AZA+ combined with umbilical cord blood stem cell microtransplantation for patients who met the inclusion criteria in higher-risk MDS(HR-MDS), CMML and sAML.
Demethylating agents are mainly decitabine (DAC) and azacitidine (AZA), both of which have been approved by the FDA for the treatment of MDS. The FDA has also approved hypomethylating agents for the treatment of CMML.Secondary acute myeloid leukemia (sAML) refers to acute myeloid leukemia with progression from a preexisting hematologic disease, such as myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPN) (excluding chronic myelomonocytic leukemia). Currently, there is no standard treatment for sAML. Based on the results of retrospective studies and clinical trials, the efficacy of hypomethylating agents in the treatment of sAML is not weaker than that of traditional intensive induction therapy and other reduced-intensity therapy or best supportive care.
The development of microtransplantation has provided new treatment modalities in patients who are not candidates for conventional allogeneic hematopoietic stem cell transplantation. In China, Huisheng Ai team proposed the concept of micro-transplantation. Micro-transplantation (MST) is a new concept and method that combines conventional chemotherapy or targeted drugs with allogeneic stem cell infusion. Microtransplantation is combined with infusion of G-CSF mobilized peripheral blood stem cells (G-PBSC) from HLA-mismatched donors on the basis of killing leukemia cells by chemotherapy or targeted drugs. Thus, donor microchimerism (donor cells <1-5%) can be formed to induce donor/recipient anti-leukemia (GVL/RVL) effect and promote hematopoietic recovery in recipients without full donor engraftment and almost no risk of GVHD. The clinical results have also been verified in several research centers in the United States, Australia, Spain and other countries, which show that micro-transplantation technology can promote hematopoietic recovery, produce graft-versus-tumor effect and recipientversus-tumor effect, and provide a new safe and effective treatment method for the treatment of hematological diseases and solid tumors.
Participants will receive unrelated umbilical cord blood transfusion during at least 1-2 cycles of treatment.The specific process is as follows:
A single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus.
Specific treatment options:
- AZA monotherapy: Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection;
- VA : Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1,200mg d2,400mg d3 to d14, orally.
- VAH :
Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1, 200mg d2,400mg d3 to d14, orally. Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected. During the period, the medication time was adjusted according to the patient's blood condition and complications If severe adverse reactions (such as grade 3 or above infection and bone marrow suppression) occurred, the next course of treatment was postponed according to the situation.
Microtransplantation of umbilical cord blood: single unit of unrelated cord blood (HLA 0-5/10 or 0-3/6 matched, TNC 1-2×107/Kg body weight), AZA or homoharringtonine infusion 24-72 hours after the end of injection.
It is expected that about 50 patients will take part in this research study.
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia-2, Secondary Acute Myeloid Leukemia
- Being tested
- unrelated umbilical cord blood
- Keywords
- umbilical cord blood stem cell, microtransplantation, myelodysplastic syndromes, Chronic myelomonocytic leukemia, secondary acute myeloid leukemia
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unrelated umbilical cord bloodDrug
A single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus.
Microtransplantation of umbilical cord blood: single unit of unrelated cord blood (HLA 0-5/10 or 0-3/6 matched, TNC 1-2×107/Kg body weight), AZA or homoharringtonine infusion 24-72 hours after the end of injection.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | unrelated umbilical cord blood stem cell microtransplantation combined with AZA/AZA+ based treatment.
A single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus.
Specific treatment options:
1. AZA monotherapy:
Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection;
2. VA :
Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1,200mg d2,400mg d3 to d14, orally.
3. VAH:
Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1, 200mg d2,400mg d3 to d14, orally. Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected. During the period, the medication time was adjusted according to the patient's blood condition and complications Receives: Drug: unrelated umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
It is measured from the date of randomization to the date of death from any cause; patients not known to have died at least follow-up are censored on the date they were last known to be alive.
Measured: From the time of randomization to time for up to 2 years.
complete response rate
Complete remission was achieved according to the remission criteria of different diseases Complete remission was achieved according to the remission criteria of different diseases Complete remission was achieved according to the remission criteria of different diseases Complete remission was achieved according to the remission criteria of different diseases complete response rate is achieved according to the remission criteria of different diseases
Measured: from randomization to end of cycle 1-2.
Hematopoietic function recovery time
The recovery time of hematopoietic function was defined as the time from the decline of three lineages to the stable hematological response of three lineages
Measured: From the time of randomization to time for up to 2 years.
Secondary outcomes (3)
The 2-year overall survival rate
The 2-year survival rate was calculated as the number of surviving cases/the total number of cases followed up for 2 years
Measured: From the time of randomization to time for up to 2 years.
disease-free survival
The disease-free survival was calculated as the time from randomization to disease recurrence or death due to disease progression
Measured: From the time of randomization to time for up to 2 years.
Early mortality
Early mortality was defined as death within the first 3 months after initiation of induction therapy
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584761
- Sponsor's protocol ID
- 2022-SR-271
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 18 Oct 2022
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective, Multicenter, Open-label and Observational Trial for Unrelated Umbilical Cord Blood Stem Cell Microtransplantation Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and Secondary AML.
- ClinicalTrials.gov ID
- NCT05584761
- Acronym / sponsor ID
- 2022-SR-271
- Conditions
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia-2, Secondary Acute Myeloid Leukemia
- Keywords
- umbilical cord blood stem cell, microtransplantation, myelodysplastic syndromes, Chronic myelomonocytic leukemia, secondary acute myeloid leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 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.
This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). The study protocol involved unrelated umbilical cord blood stem cell combined with azacitidine based treatment, which including azacitidine alone and azacitidine plus a targeted agent or chemotherapy agent.
Detailed description
This is a perspective, multicenter, open-label and observational trial for unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine based treatment for advanced MDS,CMML-2 and secondary AML. The study protocol is AZA /AZA+ combined with umbilical cord blood stem cell microtransplantation for patients who met the inclusion criteria in higher-risk MDS(HR-MDS), CMML and sAML.
Demethylating agents are mainly decitabine (DAC) and azacitidine (AZA), both of which have been approved by the FDA for the treatment of MDS. The FDA has also approved hypomethylating agents for the treatment of CMML.Secondary acute myeloid leukemia (sAML) refers to acute myeloid leukemia with progression from a preexisting hematologic disease, such as myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPN) (excluding chronic myelomonocytic leukemia). Currently, there is no standard treatment for sAML. Based on the results of retrospective studies and clinical trials, the efficacy of hypomethylating agents in the treatment of sAML is not weaker than that of traditional intensive induction therapy and other reduced-intensity therapy or best supportive care.
The development of microtransplantation has provided new treatment modalities in patients who are not candidates for conventional allogeneic hematopoietic stem cell transplantation. In China, Huisheng Ai team proposed the concept of micro-transplantation. Micro-transplantation (MST) is a new concept and method that combines conventional chemotherapy or targeted drugs with allogeneic stem cell infusion. Microtransplantation is combined with infusion of G-CSF mobilized peripheral blood stem cells (G-PBSC) from HLA-mismatched donors on the basis of killing leukemia cells by chemotherapy or targeted drugs. Thus, donor microchimerism (donor cells <1-5%) can be formed to induce donor/recipient anti-leukemia (GVL/RVL) effect and promote hematopoietic recovery in recipients without full donor engraftment and almost no risk of GVHD. The clinical results have also been verified in several research centers in the United States, Australia, Spain and other countries, which show that micro-transplantation technology can promote hematopoietic recovery, produce graft-versus-tumor effect and recipientversus-tumor effect, and provide a new safe and effective treatment method for the treatment of hematological diseases and solid tumors.
Participants will receive unrelated umbilical cord blood transfusion during at least 1-2 cycles of treatment.The specific process is as follows:
A single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus.
Specific treatment options:
- AZA monotherapy: Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection;
- VA : Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1,200mg d2,400mg d3 to d14, orally.
- VAH :
Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1, 200mg d2,400mg d3 to d14, orally. Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected. During the period, the medication time was adjusted according to the patient's blood condition and complications If severe adverse reactions (such as grade 3 or above infection and bone marrow suppression) occurred, the next course of treatment was postponed according to the situation.
Microtransplantation of umbilical cord blood: single unit of unrelated cord blood (HLA 0-5/10 or 0-3/6 matched, TNC 1-2×107/Kg body weight), AZA or homoharringtonine infusion 24-72 hours after the end of injection.
It is expected that about 50 patients will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: unrelated umbilical cord bloodunrelated umbilical cord blood stem cell microtransplantation combined with AZA/AZA+ based treatment. A single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus. Specific treatment options: 1. AZA monotherapy: Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; 2. VA : Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1,200mg d2,400mg d3 to d14, orally. 3. VAH: Azacitidine 75mg·m-2·d-1, d1-d7, subcutaneous injection; Venetoclax (VEN) 100mg d1, 200mg d2,400mg d3 to d14, orally. Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected. During the period, the medication time was adjusted according to the patient's blood condition and complications |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- BCR/ABL positive chronic myelogenous leukemia, primary myelofibrosis, polycythemia vera and essential thrombocythemia;
- Low risk myelodysplastic syndromes according to IPSS or revised IPSS prognostic risk categories;
- Acute promyelocytic leukemia, myeloid sarcoma, or accelerated or blastic phase of chronic myelogenous leukemia;
- Allergic to any of the mentioned agent in the study protocol;
- Pregnant or lactating women, or patients during reproductive stage but not willing to take contraception methods;
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 |
|---|---|---|
| unrelated umbilical cord bloodA single unit of unrelated umbilical cord blood was reinfused within 24-72 hours after the end of AZA or chemotherapy, and the longest delay was 96 hours after the end of chemotherapy. The umbilical cord blood was matched at 0-3/10 locus. Microtransplantation of umbilical cord blood: single unit of unrelated cord blood (HLA 0-5/10 or 0-3/6 matched, TNC 1-2×107/Kg body weight), AZA or homoharringtonine infusion 24-72 hours after the end of injection. | Drug | experimental group |
Primary outcome
overall survival rate
Time frame: From the time of randomization to time for up to 2 years.
It is measured from the date of randomization to the date of death from any cause; patients not known to have died at least follow-up are censored on the date they were last known to be alive.
complete response rate
Time frame: from randomization to end of cycle 1-2.
Complete remission was achieved according to the remission criteria of different diseases Complete remission was achieved according to the remission criteria of different diseases Complete remission was achieved according to the remission criteria of different diseases Complete remission was achieved according to the remission criteria of different diseases complete response rate is achieved according to the remission criteria of different diseases
Hematopoietic function recovery time
Time frame: From the time of randomization to time for up to 2 years.
The recovery time of hematopoietic function was defined as the time from the decline of three lineages to the stable hematological response of three lineages
3 secondary outcomes
The 2-year overall survival rate
Time frame: From the time of randomization to time for up to 2 years.
disease-free survival
Time frame: From the time of randomization to time for up to 2 years.
Early mortality
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Myelodysplastic Syndromes
RecruitingObservational study
Collection of Tissue Samples for Cancer Research
Neoplasms, Lymphomas
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 2
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 2
Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)
Myelodysplastic Syndrome
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.
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 unrelated umbilical cord blood in people with Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia-2, run by The First Affiliated Hospital with Nanjing Medical 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 0 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 18 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Huang, MD (+8615950523133, huangfei0815@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival rate (time frame: From the time of randomization to time for up to 2 years.). The study lists 3 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 18 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.