Marginal Zone Lymphoma(MZL)Phase 4NCT07355699
Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma
A Phase 4 study testing Orelabrutinib in people with Marginal Zone Lymphoma(MZL), run by Beijing Tongren Hospital at 3 sites in China.
Trial summary
This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody. This is a single-arm study without a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma(MZL)
- What is being tested?
- Orelabrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesChina
- Study dates
- 25 Nov 2025to 31 Dec 2028
- Phase
- Phase 4
- 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
- Age ≥ 18 years;
- Pathologically confirmed marginal zone lymphoma;
- Presence of evaluable lesions;
- Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment;
- Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered unsuitable for local radiotherapy include the following:
- Gastric MALT MZL, Ann Arbor stage I, that is H. pylori-negative, or H. pylori-positive gastric MALT MZL (Ann Arbor stage I) with poor response to H. pylori eradication therapy;
Show all 14Show fewer
- Non-gastric MALT and nodal MZL in Ann Arbor non-contiguous stage II or stages III-IV;
- SMZL;
- Gastric MALT classified as Lugano II2, IIE, or IV stage;
- Patient intolerance to radiotherapy;
- Other MZL patients deemed unsuitable for local radiotherapy by the investigator.
- ECOG score of 0-3;
- Expected survival time ≥ 3 months;
- Ability to provide signed informed consent.
Who cannot join
- Currently diagnosed with another malignant tumor;
- Central nervous system involvement by lymphoma or transformation to a higher grade;
- Allergy to any of the investigational drugs;
- Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases;
- Pregnancy, lactating women, or subjects of childbearing potential unwilling to use contraception;
- Other situations deemed by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing
Liang Wang, PhD, +86 15013009093, wangliangtrhos@126.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
Wei Zhang, PhD, +86 13681473557, vv1223@vip.sina.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Beijing
Xiaojing Yan, PhD, +86 13889128302, yanxiaojingpp@hotmail.com
About this study
Official title: Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma:A Phase II, Prospective, Multicenter, Single-Arm Clinical Study
This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody.
This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:
Read more
- Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy. Sample size: 50 cases.
- Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 [C1], and on Day 1 of Cycles 2-6 [C2-C6]).
Target population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.
Sample size: 38 cases.
Read the detailed description
This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody. Given the current lack of a standard first-line treatment regimen for MZL, and the limited efficacy and significant side effects associated with commonly used immunochemotherapy regimens, chemotherapy-free approaches have attracted considerable attention. As a domestically developed new-generation BTK inhibitor, orelabrutinib exhibits high selectivity and a favorable safety profile, and demonstrates synergistic effects with CD20 monoclonal antibodies. The study enrolls treatment-naïve MZL patients at different stages, administering either orelabrutinib monotherapy or combination therapy with a CD20 monoclonal antibody. Efficacy indicators, such as overall response rate and complete response rate, are closely monitored, with tumor changes assessed through regular imaging and laboratory examinations. Meanwhile, all types of adverse reactions are documented in detail to evaluate safety. Long-term follow-up is conducted to track progression-free survival and overall survival, comprehensively analyzing whether this combination regimen can emerge as a highly effective, low-toxicity, chemotherapy-free option.
This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:
- Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy. Sample size: 50 cases.
- Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 [C1], and on Day 1 of Cycles 2-6 [C2-C6]).
Target population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.
Sample size: 38 cases.
- Conditions
- Marginal Zone Lymphoma(MZL)
- Being tested
- Orelabrutinib
- Keywords
- Marginal Zone Lymphoma, Orelabrutinib, CD20 Monoclonal Antibody
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
Also called Rituximab, Obinutuzumab
- Stage I MZL Patients: Treatment with Orelabrutinib monotherapy. Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-21 (d1-d21) of each cycle.
- Stage II-IV MZL Patients:
Treatment with the Orelabrutinib plus CD20 monoclonal antibody regimen, divided into an induction phase and a maintenance phase.
Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (150mg qd d1-d21/C1-C6). Concurrently, a CD20 monoclonal antibody is used: either Rituximab 375mg/m² intravenously (iv) on Day 1 of each cycle (d1/C1-C6); or Obinutuzumab, administered as 1000mg intravenously on Days 1, 8, and 15 of Cycle 1 (1000mg iv d1,d8,d15/C1), followed by 1000mg intravenously on Day 1 of Cycles 2-6 (1000mg iv d1/C2-C6).
Maintenance Phase: If maintenance therapy is administered, during Cycles 7-30 (C7-C30), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-28 (d1-d28) of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib-based treatments | Experimental | This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:
1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6).
2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 [C1], and on Day 1 of Cycles 2-6 [C2-C6]. Receives: Drug: Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Best Overall Response Rate (ORR): Efficacy is assessed every two treatment cycles. The best ORR achieved within the 6 treatment cycles serves as the primary endpoint.
Measured: From enrollment to the end of treatment at 21 weeks
Secondary outcomes (4)
Complete Response Rate
Best Complete Response Rate (CRR): Efficacy is assessed every two treatment cycles. The best CRR achieved within the 6 treatment cycles serves as a secondary endpoint.
Measured: From enrollment to the end of treatment at 21 weeks
2-Year Progression-Free Survival Rate
2-Year PFS (Progression-Free Survival) refers to the time interval from the date a patient begins treatment until either disease progression, relapse, or death from any cause reaches two years. If the patient does not experience disease progression and remains alive within the two-year period, they are considered to have achieved 2-year PFS. If disease progression or death occurs within the two years, 2-year PFS is not achieved.
Measured: From enrollment to 2 years
2-Year Overall Survival Rate
2-Year Overall Survival Rate (OS): OS is defined as the time from the date of study enrollment until the patient dies from any cause or is lost to follow-up.
Measured: From enrollment to 2 years
AE
Safety is evaluated according to the CTCAE v5.0 criteria. Toxicity assessments are performed during each treatment cycle, primarily focusing on hematological toxicities and non-hematological toxicities.
Measured: Through study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start25 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone Lymphoma(MZL)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
- Investigators
- Liang Wang, MD, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355699
- Sponsor's protocol ID
- TREC2025-KY209
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma:A Phase II, Prospective, Multicenter, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07355699
- Acronym / sponsor ID
- TREC2025-KY209
- Conditions
- Marginal Zone Lymphoma(MZL)
- Keywords
- Marginal Zone Lymphoma, Orelabrutinib, CD20 Monoclonal Antibody
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jan 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 focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody.
This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:
- Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy. Sample size: 50 cases.
- Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 [C1], and on Day 1 of Cycles 2-6 [C2-C6]).
Target population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.
Sample size: 38 cases.
Detailed description
This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody. Given the current lack of a standard first-line treatment regimen for MZL, and the limited efficacy and significant side effects associated with commonly used immunochemotherapy regimens, chemotherapy-free approaches have attracted considerable attention. As a domestically developed new-generation BTK inhibitor, orelabrutinib exhibits high selectivity and a favorable safety profile, and demonstrates synergistic effects with CD20 monoclonal antibodies. The study enrolls treatment-naïve MZL patients at different stages, administering either orelabrutinib monotherapy or combination therapy with a CD20 monoclonal antibody. Efficacy indicators, such as overall response rate and complete response rate, are closely monitored, with tumor changes assessed through regular imaging and laboratory examinations. Meanwhile, all types of adverse reactions are documented in detail to evaluate safety. Long-term follow-up is conducted to track progression-free survival and overall survival, comprehensively analyzing whether this combination regimen can emerge as a highly effective, low-toxicity, chemotherapy-free option.
This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:
- Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy. Sample size: 50 cases.
- Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 [C1], and on Day 1 of Cycles 2-6 [C2-C6]).
Target population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.
Sample size: 38 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib-based treatments | Experimental | Drug: OrelabrutinibThis is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups: 1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). 2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 [C1], and on Day 1 of Cycles 2-6 [C2-C6]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years;
- Pathologically confirmed marginal zone lymphoma;
- Presence of evaluable lesions;
- Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment;
- Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered unsuitable for local radiotherapy include the following:
Key exclusion criteria (6 listed)
- Currently diagnosed with another malignant tumor;
- Central nervous system involvement by lymphoma or transformation to a higher grade;
- Allergy to any of the investigational drugs;
- Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases;
- Pregnancy, lactating women, or subjects of childbearing potential unwilling to use contraception;
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 |
|---|---|---|
| OrelabrutinibAlso: Rituximab, Obinutuzumab1. Stage I MZL Patients: Treatment with Orelabrutinib monotherapy. Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-21 (d1-d21) of each cycle. 2. Stage II-IV MZL Patients: Treatment with the Orelabrutinib plus CD20 monoclonal antibody regimen, divided into an induction phase and a maintenance phase. Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (150mg qd d1-d21/C1-C6). Concurrently, a CD20 monoclonal antibody is used: either Rituximab 375mg/m² intravenously (iv) on Day 1 of each cycle (d1/C1-C6); or Obinutuzumab, administered as 1000mg intravenously on Days 1, 8, and 15 of Cycle 1 (1000mg iv d1,d8,d15/C1), followed by 1000mg intravenously on Day 1 of Cycles 2-6 (1000mg iv d1/C2-C6). Maintenance Phase: If maintenance therapy is administered, during Cycles 7-30 (C7-C30), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-28 (d1-d28) of each cycle. | Drug | Orelabrutinib-based treatments |
Primary outcome
Overall Response Rate
Time frame: From enrollment to the end of treatment at 21 weeks
Best Overall Response Rate (ORR): Efficacy is assessed every two treatment cycles. The best ORR achieved within the 6 treatment cycles serves as the primary endpoint.
4 secondary outcomes
Complete Response Rate
Time frame: From enrollment to the end of treatment at 21 weeks
2-Year Progression-Free Survival Rate
Time frame: From enrollment to 2 years
2-Year Overall Survival Rate
Time frame: From enrollment to 2 years
AE
Time frame: Through study completion, an average of 2.5 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 21 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Liang Wang, MD principal investigator
Beijing Tongren Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Orelabrutinib in people with Marginal Zone Lymphoma(MZL), run by Beijing Tongren Hospital at 3 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 14 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Liang Wang, MD (+86 15013009093, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: From enrollment to the end of treatment at 21 weeks). 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 21 Jan 2026.