DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT07677813
Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma
A Phase 2 study testing R-CHOP+Orelabrutinib, POLA-R-CHP+orelabrutinib and R-miniCHOP +orelabrutinib in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Ou Bai, MD/PHD at 1 site in China.
Trial summary
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- R-CHOP+Orelabrutinib, POLA-R-CHP+orelabrutinib and R-miniCHOP +orelabrutinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 31 Dec 2031
- Phase
- Phase 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
- Patients of any gender, aged ≥18 years;
- Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs);
- No prior treatment history;
- Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml/min;
- Bilirubin <1.5 times the upper limit of normal;
- Understand and voluntarily sign a written informed consent form.
Who cannot join
- Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
- Patients with a history of stroke or bleeding within the past 6 months;
- Patients requiring treatment with strong CYP3A inhibitors;
- Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;
- Patients with a history of organ transplantation;
- Patients with a history of or concurrent other malignant tumors.
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
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
ou bai, MD/PHD, 13039046656, oubai16@163.com
About this study
Official title: Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.
Read the detailed description
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL).
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- R-CHOP+Orelabrutinib, POLA-R-CHP+orelabrutinib, R-miniCHOP +orelabrutinib, Zuberitamab-CHOP+orelabrutinib, POLA-Hi-CHP+orelabrutinib
- Keywords
- orelabrutinib, DLBCL, chemotherapy, Maintenance therapy, MCD subtype
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-CHOP+OrelabrutinibDrug
Also called Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
R-CHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Vincristine: 1.4 mg/m², Day 1 (maximum single dose: 2 mg) Prednisone: 100 mg, Days 1-5 Orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
POLA-R-CHP+orelabrutinibDrug
Also called Rituximab, Vepoliximab, Cyclophosphamide, Doxorubicin
POLA-R-CHP+orelabrutinib Rituximab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
R-miniCHOP +orelabrutinibDrug
Also called Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
R-miniCHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Zuberitamab-CHOP+orelabrutinibDrug
Also called Zuberitamab, Cyclophosphamide, Doxorubicin, Vincristine
Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
POLA-Hi-CHP+orelabrutinibDrug
Also called Vepoliximab, Cyclophosphamide, Doxorubicin, Prednisone
POLA-Hi-CHP+orelabrutinib Zuberitamab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Hi-miniCHOP +orelabrutinibDrug
Also called Zuberitamab, Cyclophosphamide, Doxorubicin, Vincristine
Hi-miniCHOP Regimen Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
RMTODrug
Also called Rituximab, orelabrutinib, Thiotepa, Methotrexate
RMTO Regimen Rituximab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
HiMTODrug
Also called Zuberitamab, orelabrutinib, Thiotepa, Methotrexate
HiMTO Regimen Zuberitamab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Pola-R-miniCHP+ODrug
Also called Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin
Pola-R-miniCHP Regimen Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Rituximab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Pola-Hi-miniCHPDrug
Also called Polatuzumab vedotin, Cyclophosphamide, Doxorubicin, Prednisone
Pola-Hi-miniCHP Regimen (21-day cycle, up to 6 cycles) Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Zuberitamab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL | Experimental | For MCD subtype DLBCL (including IP-LBCLs) that have undergone two cycles of induction therapy, combine orelabrutinib treatment starting from the third cycle.
For patients with poor prognostic factors (meeting one of the following: Ann Arbor stage III/IV; IPI score 3-5; aaIPI score 2-3; high-intermediate or high-risk group per MSKCC and/or IELSG criteria), continue with two additional cycles of orelabrutinib-combined induction therapy, followed by orelabrutinib monotherapy maintenance for 2 years or until disease progression or intolerable toxicity.
For patients without poor prognostic factors, administer orelabrutinib monotherapy maintenance for 1 year or until disease progression or intolerable toxicity. Receives: Drug: R-CHOP+Orelabrutinib; Drug: POLA-R-CHP+orelabrutinib; Drug: R-miniCHOP +orelabrutinib; Drug: Zuberitamab-CHOP+orelabrutinib; Drug: POLA-Hi-CHP+orelabrutinib; Drug: Hi-miniCHOP +orelabrutinib; Drug: RMTO; Drug: HiMTO; Drug: Pola-R-miniCHP+O; Drug: Pola-Hi-miniCHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
2year PFS
The percentage of subjects who had not experienced disease progression or all-cause death at 24 months from first dose, relative to the total enrolled population.
Measured: From the start of treatment up to 2 years
Secondary outcomes (4)
ORR
The proportion of patients who achieved a PR or better response at the end of therapy
Measured: From the start of treatment up to 2 years
CRR
Proportion of patients achieving CR at the end of treatment
Measured: From the start of treatment up to 2 years
OS
Time from treatment initiation to death from any cause
Measured: From the start of treatment up to 2 years
AEs
All adverse medical events that occurred after the initiation of treatment
Measured: From the start of treatment up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start16 Jun 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ou Bai, MD/PHD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677813
- Sponsor's protocol ID
- 25K405-001
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT07677813
- Acronym / sponsor ID
- 25K405-001
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- orelabrutinib, DLBCL, chemotherapy, Maintenance therapy, MCD subtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ou Bai, MD/PHDUniversity, hospital or other
- Study start
- 16 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 Jul 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 is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.
Detailed description
This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL | Experimental | Drug: R-CHOP+Orelabrutinib, Drug: POLA-R-CHP+orelabrutinib, Drug: R-miniCHOP +orelabrutinib, Drug: Zuberitamab-CHOP+orelabrutinib, Drug: POLA-Hi-CHP+orelabrutinib, Drug: Hi-miniCHOP +orelabrutinib, Drug: RMTO, Drug: HiMTO, Drug: Pola-R-miniCHP+O, Drug: Pola-Hi-miniCHPFor MCD subtype DLBCL (including IP-LBCLs) that have undergone two cycles of induction therapy, combine orelabrutinib treatment starting from the third cycle. For patients with poor prognostic factors (meeting one of the following: Ann Arbor stage III/IV; IPI score 3-5; aaIPI score 2-3; high-intermediate or high-risk group per MSKCC and/or IELSG criteria), continue with two additional cycles of orelabrutinib-combined induction therapy, followed by orelabrutinib monotherapy maintenance for 2 years or until disease progression or intolerable toxicity. For patients without poor prognostic factors, administer orelabrutinib monotherapy maintenance for 1 year or until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of any gender, aged ≥18 years;
- Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs);
- No prior treatment history;
- Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml/min;
- Bilirubin <1.5 times the upper limit of normal;
Key exclusion criteria (6 listed)
- Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
- Patients with a history of stroke or bleeding within the past 6 months;
- Patients requiring treatment with strong CYP3A inhibitors;
- Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;
- Patients with a history of organ transplantation;
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 |
|---|---|---|
| R-CHOP+OrelabrutinibAlso: Rituximab, Cyclophosphamide, Doxorubicin, VincristineR-CHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Vincristine: 1.4 mg/m², Day 1 (maximum single dose: 2 mg) Prednisone: 100 mg, Days 1-5 Orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| POLA-R-CHP+orelabrutinibAlso: Rituximab, Vepoliximab, Cyclophosphamide, DoxorubicinPOLA-R-CHP+orelabrutinib Rituximab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| R-miniCHOP +orelabrutinibAlso: Rituximab, Cyclophosphamide, Doxorubicin, VincristineR-miniCHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| Zuberitamab-CHOP+orelabrutinibAlso: Zuberitamab, Cyclophosphamide, Doxorubicin, VincristineZuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| POLA-Hi-CHP+orelabrutinibAlso: Vepoliximab, Cyclophosphamide, Doxorubicin, PrednisonePOLA-Hi-CHP+orelabrutinib Zuberitamab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| Hi-miniCHOP +orelabrutinibAlso: Zuberitamab, Cyclophosphamide, Doxorubicin, VincristineHi-miniCHOP Regimen Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| RMTOAlso: Rituximab, orelabrutinib, Thiotepa, MethotrexateRMTO Regimen Rituximab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| HiMTOAlso: Zuberitamab, orelabrutinib, Thiotepa, MethotrexateHiMTO Regimen Zuberitamab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| Pola-R-miniCHP+OAlso: Polatuzumab vedotin, Rituximab, Cyclophosphamide, DoxorubicinPola-R-miniCHP Regimen Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Rituximab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
| Pola-Hi-miniCHPAlso: Polatuzumab vedotin, Cyclophosphamide, Doxorubicin, PrednisonePola-Hi-miniCHP Regimen (21-day cycle, up to 6 cycles) Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Zuberitamab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle | Drug | Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL |
Primary outcome
2year PFS
Time frame: From the start of treatment up to 2 years
The percentage of subjects who had not experienced disease progression or all-cause death at 24 months from first dose, relative to the total enrolled population.
4 secondary outcomes
ORR
Time frame: From the start of treatment up to 2 years
CRR
Time frame: From the start of treatment up to 2 years
OS
Time frame: From the start of treatment up to 2 years
AEs
Time frame: From the start of treatment up to 2 years
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-CHOP+Orelabrutinib, POLA-R-CHP+orelabrutinib and R-miniCHOP +orelabrutinib in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Ou Bai, MD/PHD 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 1 Jul 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.
What does this phase mean?
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 ou bai, MD/PHD (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2year PFS (time frame: From the start of treatment up to 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 1 Jul 2026.