Colorectal CancerPhase 1/2NCT07653685
A Clinical Trial Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Patients With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
A Phase 1/2 study testing TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection and TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets) in people with Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 31 sites in China.
Trial summary
To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in sparticipants with HER2-Abnormally Expressed locally advanced or metastatic colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection and TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 31 sitesChina
- Study dates
- 3 Sep 2026to Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily participate in this study, sign the informed consent form, and have good compliance
- Age: 18-75 years (including the boundary when signing the informed consent form)
- Eastern Cooperative Oncology Group (ECOG) score: 0-1
- Expected survival of more than 3 months
- Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology
- HER2-Abnormally Expressed tested
- Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Participants should agree to use contraception during the study and for 6 months after the end
Who cannot join
- Participants with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR)
- Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications
- Active inflammatory bowel disease within 28 days prior to first dose
- Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies
- Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy
- Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment
Show all 20Show fewer
- Had wounds or fractures that had not been healed for a long time
- Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose
- Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders
- Participants with any severe and/or uncontrolled disease
- Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks
- Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study
- Failure to control serous effusions requiring repeated drainage
- Local radiotherapy or 4. Bone marrow irradiation > 30% for bone metastasis before the first medication
- Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain
- Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication;
- Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment
- History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study;
- Previous history of severe allergy of unknown origin
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the participants' safety or affect the completion of the study, or the participant is considered unsuitable for other reasons
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites, 31 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Shikai Wu, Doctor, 15810037307, Skywu4923@sina.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130021
Hongxia Cui, Master, 13504436090, 2503074283@qq.com
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Tingting Liang, Doctor, 15804303776, liangting2006@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yi He, Doctor, 18692237222, heyi@hnca.org.cn
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Tao Zhang, Doctor, 13708311156, tumorzzt@163.com
- Not yet recruiting
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Wei Wang, Doctor, 18038863618, wangwei@fsyyy.com
- Not yet recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yanhon Den, Doctor, 13925106525, dengyanh@mail.sysu.edu.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, Doctor, 020-87343468, xurh@syscc.org.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Tongsen Zheng, Doctor, 15134569619, zhengtongsen@126.com
Yuxian Bai, Doctor, 13945095085, bai_yuxian@126.com
- Not yet recruiting
Jingzhou First People's Hospital
Jingzhou, Hubei, 434099
Yan Hu, Master, 18163137369, helensparkle@163.com
- Not yet recruiting
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050
Zhihu Li, Master, 18993042850, 245698692@qq.com
- Recruiting
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323000
Yanru Xie, Master, 13567615770, 43437677@qq.com
- Not yet recruiting
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, 330000
Weirong Yao, Doctor, 13907002901, 13907002901@126.com
- Not yet recruiting
Jiangsu Provincial Cancer Hospital
Nanjing, Jiangsu, 210000
Yuanhua Liu, Doctor, 13305180356, yuanhualiu02@hotmail.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yudong Qiu, Doctor, 13951806490, yudongqiu510@163.com
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
CaiLian Wang, Doctor, 13851756378, wangcailian65@hotmail.com
- Not yet recruiting
Guangxi Zhuang Autonomous Region Cancer Hospital
Nanning, Guangxi, 530000
Rong Liang, Doctor, 18677070811, 53371159@qq.com
- Not yet recruiting
Qiqihar First Hospital
Qiqihar, Heilongjiang, 161005
Xiyuan Sun, Doctor, 13945258792, sunxiyuan2004@126.com
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
XiuYing Xiao, Doctor, 13564579313, xiaoxiuying2002@163.com
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110000
Jingdong Zhang, Doctor, 18040007878, 13804027878@163.com
- Not yet recruiting
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, 300121
Mingqing Zhang, Doctor, 15122875158, zmq1003@163.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202
Zhanyu Pan, Master, 18622221256, tjpanzy@126.com
- Not yet recruiting
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830054
YanLi Qu, Master, 18160627963, quyanli73@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hongli Liu, Doctor, 13995680822, hongliliu@hust.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an, Shaanxi, 710000
Aili Suo, Doctor, 18991232561, Ailisuo@mail.xjtu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000
Yongzhan Nie, Doctor, 15091520001, nieyongzhan@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000
Haichuan Su, Doctor, 18629190366, cntdgcp@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Ying Liu, Doctor, 13783604602, yaya7207@126.com
- Not yet recruiting
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450000
Yongxu Jia, Doctor, 15237128281, fccjiayx@zzu.edu.cn
- Not yet recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000
HaiCun Wang, Master, 13803833783, whc1975@126.com
- Recruiting
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Jiwei Wang, Doctor, 18013964231, zmu_wangjw@163.com
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in sparticipants with HER2-Abnormally Expressed locally advanced or metastatic colorectal cancer (CRC).
- Conditions
- Colorectal Cancer
- Being tested
- TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection, TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injectionDrug
TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks VEGF binding to receptors and inhibits tumor angiogenesis.
TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)Drug
TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.
| Study group | Role | What they receive |
|---|---|---|
| TQB2930 injection +chemotherapy + Bevacizumab injection | Experimental | Not described Receives: Drug: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection |
| TQB2930 injection +chemotherapy | Active comparator | Not described Receives: Drug: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose
It refers to the safe and effective dose range that can be used for phase II study determined through phase I clinical trial.
Measured: Baseline up to 21 days
Adverse event (AE)
Incidence and severity of adverse events.
Measured: From the participants signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)
Objective Response Rate
The proportion of participants achieving complete response and partial response among the total evaluable cases.
Measured: Baseline up to 24 months
Secondary outcomes (10)
Half-life
The time it takes for the concentration of a drug in the body (usually the plasma concentration) to decrease to half of its initial value.
Measured: Baseline up to 24 months
Plasma concentration-time profiles
Total area covered under the curve plotted with time as X-axis and plasma concentration as Y-axis.
Measured: Baseline up to 24 months
Apparent clearance
The rate at which the drug is cleared from the body.
Measured: Baseline up to 24 months
Apparent terminal volume of distribution
Describe the drug distribution in the body.
Measured: Baseline up to 24 months
Trough plasma concentration
Minimum plasma drug concentration level at the end of the dosing interval (before the next dosing).
Measured: Baseline up to 24 months
Disease Control Rate
The percentage of participants with a complete response, partial response, or stable disease as determined by RECIST 1.1.
Measured: Baseline up to 24 months
Duration Of Response
The time from the first assessment of the tumor as a complete response or partial response to the first occurrence of disease progression or death from any cause.
Measured: Baseline up to 24 months
Progression Free Survival
Progression Free Survival (PFS) is defined as the length of time from the start of treatment until the disease progresses or the patient dies from any cause.
Measured: Baseline up to 24 months
Overall Survival
The time from the start of initial treatment to death from any cause.
Measured: Baseline up to 24 months
Anti-Drug Antibodies (ADA) incidence
Proportion of anti-drug antibody produced in the population of patients using the drug.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start3 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653685
- Sponsor's protocol ID
- TQB2930-Ib/II-02
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 22 Sep 2026
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT07653685
- Acronym / sponsor ID
- TQB2930-Ib/II-02
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jun 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.
To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in sparticipants with HER2-Abnormally Expressed locally advanced or metastatic colorectal cancer (CRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2930 injection +chemotherapy + Bevacizumab injection | Experimental | Drug: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection |
| TQB2930 injection +chemotherapy | Active comparator | Drug: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants voluntarily participate in this study, sign the informed consent form, and have good compliance
- Age: 18-75 years (including the boundary when signing the informed consent form)
- Eastern Cooperative Oncology Group (ECOG) score: 0-1
- Expected survival of more than 3 months
- Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology
Key exclusion criteria (20 listed)
- Participants with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR)
- Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications
- Active inflammatory bowel disease within 28 days prior to first dose
- Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies
- Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy
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 |
|---|---|---|
| TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injectionTQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks VEGF binding to receptors and inhibits tumor angiogenesis. | Drug | TQB2930 injection +chemotherapy + Bevacizumab injection |
| TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. | Drug | TQB2930 injection +chemotherapy |
Primary outcome
Recommended Phase 2 Dose
Time frame: Baseline up to 21 days
It refers to the safe and effective dose range that can be used for phase II study determined through phase I clinical trial.
Adverse event (AE)
Time frame: From the participants signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)
Incidence and severity of adverse events.
Objective Response Rate
Time frame: Baseline up to 24 months
The proportion of participants achieving complete response and partial response among the total evaluable cases.
10 secondary outcomes
Half-life
Time frame: Baseline up to 24 months
Plasma concentration-time profiles
Time frame: Baseline up to 24 months
Apparent clearance
Time frame: Baseline up to 24 months
Apparent terminal volume of distribution
Time frame: Baseline up to 24 months
Trough plasma concentration
Time frame: Baseline up to 24 months
Disease Control Rate
Time frame: Baseline up to 24 months
Duration Of Response
Time frame: Baseline up to 24 months
Progression Free Survival
Time frame: Baseline up to 24 months
Overall Survival
Time frame: Baseline up to 24 months
Anti-Drug Antibodies (ADA) incidence
Time frame: Baseline up to 24 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 22 Sep 2026.
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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.
31 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 TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection and TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets) in people with Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 31 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 8 inclusion and 20 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 Ruihua Xu, Doctor (020-87343468, xurh@syscc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (time frame: Baseline up to 21 days). 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 22 Sep 2026.