MyelofibrosisPhase 1/2NCT06122831
A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)
A Phase 1/2 study testing TQ05105 Tablets and TQB3617 Capsules in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 sites in China.
Trial summary
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- TQ05105 Tablets and TQB3617 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 22 sitesChina
- Study dates
- 12 Dec 2023to Apr 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary and signed informed consent, good compliance.
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy ≥ 24 weeks.
- Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post PV MF), or post essential thrombocythemia myelofibrosis (post ET MF)
- According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated.
- Within 7 days before the first administration, the symptom score of myeloproliferative neoplasms should meet certain requirements.
- Patients with poor efficacy of JAK inhibitors (for phase Ib and phase II cohort 2, cohort 3)
Show all 12Show fewer
- Patients who had not received JAK inhibitor treatment (for phase II cohort 1).
- Spleen enlargement.
- Peripheral blood primary cells and bone marrow primary cells were ≤10%.
- No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration.
- The Main organ function is normal.
- Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotrophin (HCG) test is not negative within 7 days before the first administration and must be non-lactating patients.
Who cannot join
- Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
- Previous treatment with BET inhibitors combined with JAK inhibitor;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate withdrawal requirements for hydroxyurea, JAK inhibitors, androgen drugs, erythropoietin, long-acting recombinant interferon-α, etc.);
- Other malignancies within 3 years prior to first administration or currently present.
- Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs;
Show all 25Show fewer
- Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
- Presence of congenital bleeding disorder and congenital coagulopathy;
- Patients who had arterial/venous thrombosis events within 6 months before the first administration.
- Have a history of mental drug abuse, or have a mental disorder.
- Active or uncontrolled severe infection;
- Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection and HCV RNA positive, or active Corona Virus Disease 2019 (COVID-19) infection;
- Patients with grade III or above congestive heart failure, unstable angina pectoris or myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation within 6 months before the first administration;
- Unsatisfactory blood pressure control despite standard therapy;
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
- Patients with a history of immunodeficiency disease or organ transplantation;
- Patients with epilepsy requiring treatment;
- Patients who have received Chinese patent medicines with anti-tumor indications specified in the approved drug package insert of China National Medical Products Administration (NMPA) within 2 weeks before the first administration;
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
- There was a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period.
- People with known hypersensitivity to the study drug and excipients;
- Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
- Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration (except JAK inhibitor-related clinical trials).
- According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Not yet recruiting
Cangzhou People's Hosipital
Cangzhou, Hebei, 061014
Hongmei Ma, Master, 18031798229, mhm-sspc@163.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Sujun Gao, Doctor, 15843073208, sujung1963@163.com
- Not yet recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000
Xuliang Shen, Doctor, 13015365546, shenxlcyp@sohu.com
- Not yet recruiting
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067020
Zhihua Zhang, Master, 15633142905, zhangzhihua@163.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 525000
Jianyu Weng, Doctor, 13924197172, wengjianyu1969@163.com
- Not yet recruiting
The First Hospital of Harbin
Harbin, Heilongjiang, 150010
Tiejun Gong, Master, 13836027737, arc@sina.con
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Da Gao, Master, 13947130473, Gaoda72@163.com
- Not yet recruiting
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, 530016
Mei Lan, Master, 13377131268, 2750478267@qq.com
- Not yet recruiting
Central Hospital Of Minhang District, Shanghai
Shanghai, Shanghai Municipality, 200000
Yunhua Hou, Master, 18017960327, zhang_manning@qq.com
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Wen Wu, Master, 13611770009, ww10649@rjh.com.cn
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Chunkang Chang, Doctor, 13764643870, changchunkang7010@aliyun.com
- Not yet recruiting
Tai'an City Central Hospital
Tai’an, Shandong, 271099
Guanchen Bai, Master, 18653819776, bgcbgc1@163.com
- Not yet recruiting
North China of Science and Technology University Affiliated Hospital
Tangshan, Hebei, 063000
Zhenyu Yan, Doctor, 18831508262, hbyzy2011@163.com
- Not yet recruiting
People's Hospital of Tianjin City
Tianjin, Tianjin Municipality, 300122
Xingli Zhao, Doctor, 13752255454, tjsrmyyxyk@163.com
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Jianping Hao, Master, 13579876416, 13579876416@163.com
- Not yet recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430071
Zhenya Hong, Doctor, 13476158466, hongzhenya@sina.com
- Not yet recruiting
Union Hospital Tongji College Huazhong Unizersity of Science And Technology
Wuhan, Hubei, 430071
Min Zhang, Doctor, 15871818568, Zhangmin35@aliyun.com
- Not yet recruiting
Wuhan University Zhongnan Hospital
Wuhan, Hubei, 430071
Xuelan Zuo, Doctor, 13627237916, zuoxuelan2004@126.com
- Not yet recruiting
The Public Hospital of Wuxi
Wuxi, Jiangsu, 214000
Xin Zhou, Bachelor, 13358111962, zx89232@126.com
- Not yet recruiting
Xi 'An Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, 710000
Aili He, Doctor, 13891939962, heaili@xjtu.edu.cn
- Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054031
Zongjiu Jiao, Master, 18631921299, 1449569258@qq.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Hu Zhou, Doctor, 13939068863, papertigerhu@163.com
About this study
Official title: A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Intermediate- and High-risk Myelofibrosis
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis.
- Conditions
- Myelofibrosis
- Being tested
- TQ05105 Tablets, TQB3617 Capsules
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105 TabletsDrug
TQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor.
TQB3617 CapsulesDrug
TQB3617 Capsules is a Bromodomain and Extra-Terminal (BET) Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| TQ05105 Tablets + TQB3617 Capsules | Experimental | TQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle.
TQB3617 Capsules, orally administered, 21 days as a treatment cycle. Receives: Drug: TQ05105 Tablets; Drug: TQB3617 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerance dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Measured: Up to 2 years.
Recommended phase II dose (RP2D)
The RP2D is defined as the lower dose level to MTD based on the safety profile.
Measured: Up to 2 years
≥35% reduction in spleen volume (SVR35)
The proportion of subjects with a ≥35% reduction in spleen volume from baseline at the end of treatment at week 24.
Measured: Up to 24 weeks
Secondary outcomes (14)
SVR35
The proportion of subjects with a ≥35% reduction in spleen volume compared to baseline after treatment.
Measured: Up to 120 weeks
Optimum effective rate
The proportion of subjects with at least once spleen volume reduction ≥ 35% from baseline.
Measured: Up to 120 weeks
Onset time of splenic response
The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from baseline.
Measured: Up to 120 weeks
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)
The time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction is < 35% from baseline.
Measured: Up to 120 weeks
Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)
The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% from baseline. MPN-SAF-TSS is an effective tool for evaluating the disease burden of patients with myeloproliferative neoplasms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score. The higher the score, the more severe the symptoms are.
Measured: Up to 60 weeks
MPN-SAF TSS change
The total score of MPN-SAF TSS decreased compared with baseline. MPN-SAF-TSS is an effective tool for evaluating the disease burden of patients with myeloproliferative neoplasms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score. The higher the score, the more severe the symptoms are.
Measured: Up to 120 weeks
Variant allele frequency (VAF)
The proportion of subjects whose VAF decreased compared with baseline.
Measured: Up to 48 weeks
The proportion of subjects with gene mutation achieving SVR35
The proportion of subjects with gene mutation achieving SVR35
Measured: Up to 48 weeks
The proportion of subjects with gene mutation whose MPN-SAF TSS scale decreased by ≥ 50%
The proportion of subjects with gene mutation whose MPN-SAF TSS scale decreased by ≥ 50% compared with baseline.
Measured: Up to 48 weeks.
Progression-free survival (PFS)
The time interval from the first dose to the date of the occurrence of any of the following events, whichever occurs first:(1) Spleen volume increased by ≥25% compared with the screening period ; (2) Death caused by any cause.
Measured: Up to 120 weeks
Leukemia free survival (LFS)
The time interval from the date of the first dose to the date of any of the following events, whichever occurs first: (1) the date of the first bone marrow smear showing the original cell ≥20% ;(2) The first peripheral blood smear showed that the original cells ≥ 20% and the absolute value of the original cells ≥1×10^9/L and lasted for at least 2 weeks; (3) Death caused by any reason.
Measured: Up to 120 weeks
Overall Survival (OS)
OS is defined as the time from the first time the subject received treatment to death due to any cause.
Measured: Up to 120 weeks
Incidence of adverse events (AEs)
Incidence rate of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Measured: Baseline up to 120 weeks
Severity of adverse events (AEs)
Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Measured: Baseline up to 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start12 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122831
- Sponsor's protocol ID
- TQ05105-TQB3617-Ib/II-01
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2023
- Last updated
- 8 Dec 2025
- 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Intermediate- and High-risk Myelofibrosis
- ClinicalTrials.gov ID
- NCT06122831
- Acronym / sponsor ID
- TQ05105-TQB3617-Ib/II-01
- Conditions
- Myelofibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Nov 2023 (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 is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ05105 Tablets + TQB3617 Capsules | Experimental | Drug: TQ05105 Tablets, Drug: TQB3617 CapsulesTQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle. TQB3617 Capsules, orally administered, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary and signed informed consent, good compliance.
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy ≥ 24 weeks.
- Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post PV MF), or post essential thrombocythemia myelofibrosis (post ET MF)
- According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated.
- Within 7 days before the first administration, the symptom score of myeloproliferative neoplasms should meet certain requirements.
Key exclusion criteria (25 listed)
- Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
- Previous treatment with BET inhibitors combined with JAK inhibitor;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate withdrawal requirements for hydroxyurea, JAK inhibitors, androgen drugs, erythropoietin, long-acting recombinant interferon-α, etc.);
- Other malignancies within 3 years prior to first administration or currently present.
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 |
|---|---|---|
| TQ05105 TabletsTQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor. | Drug | TQ05105 Tablets + TQB3617 Capsules |
| TQB3617 CapsulesTQB3617 Capsules is a Bromodomain and Extra-Terminal (BET) Inhibitor | Drug | TQ05105 Tablets + TQB3617 Capsules |
Primary outcome
Maximal tolerance dose (MTD)
Time frame: Up to 2 years.
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Recommended phase II dose (RP2D)
Time frame: Up to 2 years
The RP2D is defined as the lower dose level to MTD based on the safety profile.
≥35% reduction in spleen volume (SVR35)
Time frame: Up to 24 weeks
The proportion of subjects with a ≥35% reduction in spleen volume from baseline at the end of treatment at week 24.
14 secondary outcomes
SVR35
Time frame: Up to 120 weeks
Optimum effective rate
Time frame: Up to 120 weeks
Onset time of splenic response
Time frame: Up to 120 weeks
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)
Time frame: Up to 120 weeks
Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)
Time frame: Up to 60 weeks
MPN-SAF TSS change
Time frame: Up to 120 weeks
Variant allele frequency (VAF)
Time frame: Up to 48 weeks
The proportion of subjects with gene mutation achieving SVR35
Time frame: Up to 48 weeks
The proportion of subjects with gene mutation whose MPN-SAF TSS scale decreased by ≥ 50%
Time frame: Up to 48 weeks.
Progression-free survival (PFS)
Time frame: Up to 120 weeks
Leukemia free survival (LFS)
Time frame: Up to 120 weeks
Overall Survival (OS)
Time frame: Up to 120 weeks
Incidence of adverse events (AEs)
Time frame: Baseline up to 120 weeks
Severity of adverse events (AEs)
Time frame: Baseline up to 120 weeks
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 8 Dec 2025.
Related trials for Myelofibrosis
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
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.
22 sites 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 TQ05105 Tablets and TQB3617 Capsules in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 sites 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 12 inclusion and 25 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 Chunkang Chang, Doctor (13764643870, changchunkang7010@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal tolerance dose (MTD) (time frame: 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 8 Dec 2025.