Leukemia, Myeloid, Acute(AML)VABuNCT07762508
A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients
A study testing Venetoclax, Azacitidine (AZA) and Decitabine 20 mg/m²/day for 5 days in people with Leukemia, Myeloid, Acute(AML) and Hematopoietic Stem Cell Transplantation (HSCT), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leukemia, Myeloid, Acute(AML), Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Venetoclax, Azacitidine (AZA) and Decitabine 20 mg/m²/day for 5 days
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Jul 2029
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years.
- Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy.
- Classified as non-high-risk per ELN 2022 risk stratification guidelines.
- ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2.
- Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor.
- Voluntarily signs informed consent form after full understanding of the study.
Who cannot join
- Allergy to any component of the study drugs.
- Psychiatric or psychological disorders that prevent cooperation with treatment.
- Uncontrolled systemic or local severe infection.
- Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment.
- Currently participating in or planning to participate in any other clinical study.
- Any other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.
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
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaojin Wu, MD, PhD, 512-67976360, wuxiaojin@suda.edu.cn
About this study
Official title: A Single-Arm, Prospective Clinical Study of the Efficacy and Safety of VABu Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Non-High-Risk AML Patients in CR1 With Low Performance Status (ECOG ≥ 2) or High Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI ≥ 2)
This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.
Read the detailed description
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. For patients who are unfit for intensive chemotherapy due to poor performance status or high comorbidity burden, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only potential curative treatment. However, these patients often have low transplantation rates and suboptimal outcomes with reduced-intensity conditioning regimens. Venetoclax combined with azacitidine has been established as the standard of care for unfit AML patients, demonstrating high remission rates and good tolerability. Building on this, our center has previously explored the VABu regimen (venetoclax, azacitidine, and busulfan) as a conditioning therapy in elderly AML patients undergoing allo-HSCT, with preliminary results showing reduced chemotherapy-related toxicity and a 2-year overall survival rate of approximately 70%.
This is a single-arm, prospective, single-center study. A total of 42 participants will be enrolled. Eligible participants are patients aged 18 to 70 years with non-APL AML who have achieved first complete remission (CR1), are classified as non-high-risk per ELN 2022 guidelines, and have either ECOG performance status ≥ 2 (not due to leukemia) or HCT-CI ≥ 2. All participants will receive the VABu conditioning regimen followed by allo-HSCT. The VABu regimen consists of venetoclax 600 mg/m² once daily on days -12 to -7, azacitidine 75 mg/m² once daily on days -11 to -7 (or decitabine 20 mg/m² for 5 days), cytarabine 2.0 g/m² every 12 hours on day -6, busulfan 0.8 mg/kg every 6 hours on days -5 to -3, and antithymocyte globulin (ATG) at 2.5 mg/kg/day according to donor type (haploidentical/unrelated donors on days -5 to -2, or matched sibling donors on days -3 to -2). Hematopoietic stem cell infusion occurs on day 0, followed by standard graft-versus-host disease (GVHD) prophylaxis.
The primary outcome measure is 2-year overall survival (OS). Secondary outcome measures include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). Safety will be monitored through adverse event collection and grading per CTCAE 5.0 criteria. Follow-up assessments are scheduled at weeks 1, 2, 3, 4, and months 2, 3, 6, 12 post-transplantation. The study period is from August 2026 to July 2029. Statistical analyses will be performed using SPSS and R, with Kaplan-Meier method for OS, and Cox regression and logistic regression for multivariate analyses.
- Being tested
- Venetoclax, Azacitidine (AZA), Decitabine 20 mg/m²/day for 5 days, Cytarabine (Ara-C), Busulfan (BU)
- Keywords
- Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning Regimen, Venetoclax, Azacitidine, VABu, Low Performance Status, High Comorbidity Index, Single-Arm Study, Prospective Study, AML, Allo-HSCT
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax 600 mg/m² administered orally once daily on days -12 to -7 as part of the VABu conditioning regimen for allogeneic hematopoietic stem cell transplantation. Venetoclax is a selective BCL-2 inhibitor used to enhance anti-leukemic activity.
Azacitidine (AZA)Drug
Azacitidine 75 mg/m² administered subcutaneously once daily on days -11 to -7 as part of the VABu conditioning regimen. This is one of the two optional hypomethylating agents; the alternative is decitabine 20 mg/m² for 5 days. Azacitidine has synergistic anti-leukemic effects when combined with venetoclax.
Decitabine 20 mg/m²/day for 5 daysDrug
Decitabine 20 mg/m² administered intravenously once daily for 5 days on days -11 to -7 as an alternative to azacitidine in the VABu conditioning regimen. This is one of the two optional hypomethylating agents; the alternative is azacitidine 75 mg/m² once daily. Decitabine has synergistic anti-leukemic effects when combined with venetoclax.
Cytarabine (Ara-C)Drug
Cytarabine 2.0 g/m² administered intravenously every 12 hours on day -6 as part of the VABu conditioning regimen. Intermediate-dose cytarabine is used to further eliminate minimal residual disease prior to hematopoietic stem cell infusion.
Busulfan (BU)Drug
Busulfan 0.8 mg/kg administered intravenously every 6 hours on days -5 to -3 as part of the VABu conditioning regimen. Busulfan is an alkylating agent used at reduced intensity to achieve sufficient anti-leukemic effect while minimizing organ toxicity.
Antithymocyte Globulin (ATG)Drug
Antithymocyte globulin (ATG) 2.5 mg/kg/day administered intravenously once daily for graft-versus-host disease (GVHD) prophylaxis. Haploidentical or unrelated donors: ATG given on days -5 to -2 (4 doses). Matched sibling donors: ATG given on days -3 to -2 (2 doses).
| Study group | Role | What they receive |
|---|---|---|
| VABu Conditioning Regimen | Experimental | Participants receive the VABu conditioning regimen followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The VABu regimen consists of venetoclax 600 mg/m² once daily on days -12 to -7, azacitidine 75 mg/m² once daily on days -11 to -7 (or decitabine 20 mg/m² for 5 days), cytarabine 2.0 g/m² every 12 hours on day -6, and busulfan 0.8 mg/kg every 6 hours on days -5 to -3. Antithymocyte globulin (ATG) is administered at 2.5 mg/kg/day according to donor type: haploidentical or unrelated donors receive ATG on days -5 to -2 (4 doses), while matched sibling donors receive ATG on days -3 to -2 (2 doses). Hematopoietic stem cell infusion occurs on day 0, followed by standard graft-versus-host disease (GVHD) prophylaxis. Receives: Drug: Venetoclax; Drug: Azacitidine (AZA); Drug: Decitabine 20 mg/m²/day for 5 days; Drug: Cytarabine (Ara-C); Drug: Busulfan (BU); Drug: Antithymocyte Globulin (ATG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Overall Survival (OS)
Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the end of follow-up will be censored at their last known alive date.
Measured: 2 years
Secondary outcomes (4)
2-Year Relapse-Free Survival (RFS)
Relapse-free survival is defined as the time from enrollment to the first occurrence of relapse or death from any cause, whichever occurs first. Participants alive and relapse-free at the end of follow-up will be censored at their last known disease-free date. Relapse is defined as disease recurrence confirmed by bone marrow morphology, cytogenetics, or molecular testing per ELN 2022 criteria.
Measured: 2 years
2-Year All-Cause Mortality, Transplant-Related Mortality (TRM), and Non-Relapse Mortality (NRM)
All-cause mortality is defined as death from any cause within 2 years of enrollment. Transplant-related mortality (TRM) is defined as death from any cause other than disease relapse or progression, with a focus on transplant-related complications (e.g., infection, GVHD, organ toxicity). Non-relapse mortality (NRM) is defined as death from any cause other than disease relapse or progression, and will be reported as a competing risk for relapse outcomes. The cumulative incidences of TRM and NRM will be estimated separately, and all-cause mortality will be reported as the overall proportion of deaths.
Measured: 2 years
Engraftment Failure Rate
Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 28 post-transplantation. Neutrophil engraftment is defined as an absolute neutrophil count ≥ 0.5 × 10⁹/L for three consecutive days. The rate of engraftment failure will be reported as the proportion of participants who fail to achieve engraftment by day 28.
Measured: Day 28 post-transplantation
Bloodstream Infection (BSI) Rate
Bloodstream infection is defined as the occurrence of at least one positive blood culture for a bacterial or fungal pathogen during the peri-transplantation period. The BSI rate will be reported as the proportion of participants with at least one episode of bloodstream infection from transplantation to day 28 post-transplantation.
Measured: Day 28 post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, Acute(AML)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762508
- Sponsor's protocol ID
- 2026863
- Acronym
- VABu
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision on IPD sharing will be made after the study is completed and the primary results are published, taking into consideration institutional policies, ethical approval, and patient privacy protection.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Clinical Study of the Efficacy and Safety of VABu Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Non-High-Risk AML Patients in CR1 With Low Performance Status (ECOG ≥ 2) or High Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI ≥ 2)
- ClinicalTrials.gov ID
- NCT07762508
- Acronym / sponsor ID
- VABu / 2026863
- Keywords
- Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning Regimen, Venetoclax, Azacitidine, VABu, Low Performance Status, High Comorbidity Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Aug 2026 (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 evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.
Detailed description
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. For patients who are unfit for intensive chemotherapy due to poor performance status or high comorbidity burden, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only potential curative treatment. However, these patients often have low transplantation rates and suboptimal outcomes with reduced-intensity conditioning regimens. Venetoclax combined with azacitidine has been established as the standard of care for unfit AML patients, demonstrating high remission rates and good tolerability. Building on this, our center has previously explored the VABu regimen (venetoclax, azacitidine, and busulfan) as a conditioning therapy in elderly AML patients undergoing allo-HSCT, with preliminary results showing reduced chemotherapy-related toxicity and a 2-year overall survival rate of approximately 70%.
This is a single-arm, prospective, single-center study. A total of 42 participants will be enrolled. Eligible participants are patients aged 18 to 70 years with non-APL AML who have achieved first complete remission (CR1), are classified as non-high-risk per ELN 2022 guidelines, and have either ECOG performance status ≥ 2 (not due to leukemia) or HCT-CI ≥ 2. All participants will receive the VABu conditioning regimen followed by allo-HSCT. The VABu regimen consists of venetoclax 600 mg/m² once daily on days -12 to -7, azacitidine 75 mg/m² once daily on days -11 to -7 (or decitabine 20 mg/m² for 5 days), cytarabine 2.0 g/m² every 12 hours on day -6, busulfan 0.8 mg/kg every 6 hours on days -5 to -3, and antithymocyte globulin (ATG) at 2.5 mg/kg/day according to donor type (haploidentical/unrelated donors on days -5 to -2, or matched sibling donors on days -3 to -2). Hematopoietic stem cell infusion occurs on day 0, followed by standard graft-versus-host disease (GVHD) prophylaxis.
The primary outcome measure is 2-year overall survival (OS). Secondary outcome measures include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). Safety will be monitored through adverse event collection and grading per CTCAE 5.0 criteria. Follow-up assessments are scheduled at weeks 1, 2, 3, 4, and months 2, 3, 6, 12 post-transplantation. The study period is from August 2026 to July 2029. Statistical analyses will be performed using SPSS and R, with Kaplan-Meier method for OS, and Cox regression and logistic regression for multivariate analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VABu Conditioning Regimen | Experimental | Drug: Venetoclax, Drug: Azacitidine (AZA), Drug: Decitabine 20 mg/m²/day for 5 days, Drug: Cytarabine (Ara-C), Drug: Busulfan (BU), Drug: Antithymocyte Globulin (ATG)Participants receive the VABu conditioning regimen followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The VABu regimen consists of venetoclax 600 mg/m² once daily on days -12 to -7, azacitidine 75 mg/m² once daily on days -11 to -7 (or decitabine 20 mg/m² for 5 days), cytarabine 2.0 g/m² every 12 hours on day -6, and busulfan 0.8 mg/kg every 6 hours on days -5 to -3. Antithymocyte globulin (ATG) is administered at 2.5 mg/kg/day according to donor type: haploidentical or unrelated donors receive ATG on days -5 to -2 (4 doses), while matched sibling donors receive ATG on days -3 to -2 (2 doses). Hematopoietic stem cell infusion occurs on day 0, followed by standard graft-versus-host disease (GVHD) prophylaxis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 70 years.
- Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy.
- Classified as non-high-risk per ELN 2022 risk stratification guidelines.
- ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2.
- Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor.
Key exclusion criteria (6 listed)
- Allergy to any component of the study drugs.
- Psychiatric or psychological disorders that prevent cooperation with treatment.
- Uncontrolled systemic or local severe infection.
- Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment.
- Currently participating in or planning to participate in any other clinical study.
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 |
|---|---|---|
| VenetoclaxVenetoclax 600 mg/m² administered orally once daily on days -12 to -7 as part of the VABu conditioning regimen for allogeneic hematopoietic stem cell transplantation. Venetoclax is a selective BCL-2 inhibitor used to enhance anti-leukemic activity. | Drug | VABu Conditioning Regimen |
| Azacitidine (AZA)Azacitidine 75 mg/m² administered subcutaneously once daily on days -11 to -7 as part of the VABu conditioning regimen. This is one of the two optional hypomethylating agents; the alternative is decitabine 20 mg/m² for 5 days. Azacitidine has synergistic anti-leukemic effects when combined with venetoclax. | Drug | VABu Conditioning Regimen |
| Decitabine 20 mg/m²/day for 5 daysDecitabine 20 mg/m² administered intravenously once daily for 5 days on days -11 to -7 as an alternative to azacitidine in the VABu conditioning regimen. This is one of the two optional hypomethylating agents; the alternative is azacitidine 75 mg/m² once daily. Decitabine has synergistic anti-leukemic effects when combined with venetoclax. | Drug | VABu Conditioning Regimen |
| Cytarabine (Ara-C)Cytarabine 2.0 g/m² administered intravenously every 12 hours on day -6 as part of the VABu conditioning regimen. Intermediate-dose cytarabine is used to further eliminate minimal residual disease prior to hematopoietic stem cell infusion. | Drug | VABu Conditioning Regimen |
| Busulfan (BU)Busulfan 0.8 mg/kg administered intravenously every 6 hours on days -5 to -3 as part of the VABu conditioning regimen. Busulfan is an alkylating agent used at reduced intensity to achieve sufficient anti-leukemic effect while minimizing organ toxicity. | Drug | VABu Conditioning Regimen |
| Antithymocyte Globulin (ATG)Antithymocyte globulin (ATG) 2.5 mg/kg/day administered intravenously once daily for graft-versus-host disease (GVHD) prophylaxis. Haploidentical or unrelated donors: ATG given on days -5 to -2 (4 doses). Matched sibling donors: ATG given on days -3 to -2 (2 doses). | Drug | VABu Conditioning Regimen |
Primary outcome
2-Year Overall Survival (OS)
Time frame: 2 years
Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the end of follow-up will be censored at their last known alive date.
4 secondary outcomes
2-Year Relapse-Free Survival (RFS)
Time frame: 2 years
2-Year All-Cause Mortality, Transplant-Related Mortality (TRM), and Non-Relapse Mortality (NRM)
Time frame: 2 years
Engraftment Failure Rate
Time frame: Day 28 post-transplantation
Bloodstream Infection (BSI) Rate
Time frame: Day 28 post-transplantation
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided. The decision on IPD sharing will be made after the study is completed and the primary results are published, taking into consideration institutional policies, ethical approval, and patient privacy protection.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venetoclax, Azacitidine (AZA) and Decitabine 20 mg/m²/day for 5 days in people with Leukemia, Myeloid, Acute(AML) and Hematopoietic Stem Cell Transplantation (HSCT), run by The First Affiliated Hospital of Soochow 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Aug 2026. 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.
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 Depei Wu, MD, PhD (512-67781856, wudepei@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Overall Survival (OS) (time frame: 2 years). 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 19 Aug 2026.