SarcomaPhase 2NCT04025931
Chidamide Combined With Toripalimab in Sarcoma
A Phase 2 study testing chidamide and toripalimab in people with Sarcoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Soft tissue sarcoma is a relatively rare malignant tumor with an incidence of about 1-2/100,000. The best way to obtain evidence-based medical evidence is to participate in clinical trials with new drugs (especially targeted drugs and immunotherapy). Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- chidamide and toripalimab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2020to 28 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients voluntarily participated in this study and signed the informed consent;
- The pathology diagnosed with at least one measurable lesion according to RECIST 1.1 standard. The pathology includes synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, dermatofibrosareoma promberans, ewing's sarcoma /primary neural ectoderm tumors, desmoplastic small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma. Except for chondrosarcoma, osteosarcoma, malignant mesothelioma, alveolar soft tissue sarcoma, gastrointestinal stromal tumor;
- Advanced sarcoma patients with refractory or distant metastasis after failure of first-line standard therapy;
- 14 ~ 70 years old; ECOG PS score: 0~1; Expected survival beyond 3 months;
- Adequate organ and bone marrow function, no serious hematopoietic dysfunction or heart, lung, liver, kidney, thyroid dysfunction and immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other medical support was received within 14 days before the use of the research drug):
- Major organs functions should meet the following standards within 7 days before treatment:
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- Blood routine examination standard (without blood transfusion within 14 days) :
- Hemoglobin (HB) ≥90g/L; The absolute value of neutrophils (ANC) ≥1.5×109/L; Platelet (PLT) ≥80 ×109/L.
- Biochemical examination shall meet the following standards:
- Total bilirubin (TBIL) ≤ 1.5 times ULN (Upper Limit Of Normal); alanine aminotransferase （ALT）and aspartate aminotransferase AST≤2.5 times ULN. If accompanied by liver metastasis, ALT and AST≤5 times ULN；Serum creatinine（Cr）≤1.5 times ULN or creatinine clearance rate (CCr)≥ 60ml/min； Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%).
- Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within 6 months after the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating;
- Men should agree to use contraceptives during and within 6 months after the study period.
Who cannot join
- Patients who have previously used chidamide or other histone deacetylase inhibitors;
- Previous treatment with immunological checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);
- Other malignancies that have occurred or are present at the same time within 5 years, except for cured cancers including carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Start the study of systemic anti-cancer therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer).
- The patients received Chinese herbal medicine or Chinese patent medicine treatment within 7 days before the start of the study.
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy (or mitomycin C administration within 6 weeks before the treatment with the experimental drug), is planned within 4 weeks before enrollment or during the medication period of this study. In the first 4 weeks of enrollment, the patients were treated with field expanding radiotherapy (ef-rt) or the limited field radiotherapy designed to evaluate tumor lesions in the first 2 weeks of enrollment.
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- Accompanied by pleural effusion or ascites, causing respiratory syndrome (CTCAE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath when there is a small amount of activity; it affects instrumental daily life activities]);
- Unrelieved toxic reactions caused by any previous treatment higher than CTCAE (4.1) level 1 or above, excluding hair loss;
- Patients with brain metastases with symptoms or with symptoms for less than 2 months;
- Patients with any severe and/or uncontrolled disease, including:
- 1)Patients with unsatisfactory blood pressure control (systolic blood pressure 150 mmHg, diastolic blood pressure 100 mmHg); 2)Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC 480ms) and grade II congestive heart failure (NYHA classification); 3)Active or uncontrolled severe infection (CTCAE grade 2 infection); 4)Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 7)Poor control of diabetes mellitus (FBG) > 10mmol/L); 8)Urine routine test indicated urine protein ++, and confirmed the 24-hour urine protein quantitative > 1.0g; 9)Patients with seizures requiring treatment;
- 11. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment;
- 12. Patients with any signs of bleeding constitution or medical history, regardless of the severity; Patients with any bleeding or bleeding event CTCAE level 3 within 4 weeks before enrollment have unhealed wounds, ulcers or fractures;
- 13. Hyperactive/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
- 14. Patients with active ulcer, intestinal perforation and intestinal obstruction;
- 15. Have a history of mental drug abuse and cannot quit or have mental disorder;
- 16. Participated in clinical trials of other anti-tumor drugs within 28 days before enrollment;
- 17.According to the judgment of the researcher, there are those who seriously endanger the safety of patients or affect the patients' completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Multi-center, Open, Phase II Study of Chidamide Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma
Soft tissue sarcoma is a relatively rare malignant tumor with an incidence of about 1-2/100,000. The best way to obtain evidence-based medical evidence is to participate in clinical trials with new drugs (especially targeted drugs and immunotherapy). Chidamide, an oral subtype-selective histone deacetylase inhibitor monotherapy was effective on the patients with hematological tumors by inhibiting HDAC activity and other ways, showing good anti-tumor activity. Histone deacetylase inhibitors (HDACi) may also reverse drug resistance or inefficiency of immunoassay inhibitors, and combination therapy has shown preliminary efficacy in a variety of tumors.Because of the poor prognosis of advanced soft tissue sarcoma, there is no standard second-line treatment. Therefore, we think it is necessary to explore the feasibility of combination of chidamide and Toripalimab monoclonal antibody in advanced, refractory and progressive soft tissue sarcoma after failure of standard treatment, and look forward to further improving the efficacy of soft tissue sarcoma.
Read the detailed description
Histone deacetylase inhibitor (HDACI) can inhibit many kinds of hematological tumors by inhibiting HDAC activity and other ways, showing good anti-tumor activity. Chidamide is a new chemical structure benzamide HDAC inhibitor developed independently in China. It has the selectivity of HDAC subtypes and unique efficacy. In a phase II clinical study of Chidamide in the treatment of peripheral T-cell lymphoma in China in 2009, 79 patients with recurrent or refractory lymphoma had ORR of 27.9%. The 2016 edition of the Chinese Expert Consensus on Chidamide in the Treatment of PTCL discussed in detail the treatment of Chidamide alone or in combination with other drugs.
The representative drug of immunological checkpoint inhibitors is programmed death 1 (PD-1/PD-L1). PD-1/PD-L1 immunotherapy activates the body's own immune system to attack cancer cells by blocking the PD-1/PD-L1 pathway with drugs. Immunotherapy show its long-term control of cancer and its effectiveness in a variety of cancers.
In a multicenter phase II clinical trial, 80 patients with bone and soft tissue sarcoma were treated with single drug of PD-1 antibody Pembrolizumab. The results showed that all the patients with soft tissue sarcoma achieved therapeutic effect were undifferentiated pleomorphic sarcoma and liposarcoma. The overall objective remission rate was 18% (7/40), suggesting that Pembrolizumab alone does not fully activate suppressed T cells, and may need to be combined to improve the efficacy.
Recent studies have shown that combination of epigenetic regulators, such as histone deacetylase inhibitors (HDACi), can overcome some major drug resistance constraints and ensure patient safety. Pre-clinical data based on mouse models strongly support the feasibility and effectiveness of combination therapy. In vitro and in vivo studies, combined use of pan- or class I selective HDACi can benefit further. Chidamide is mainly targeted at subtypes 1, 2, 3 and 10 of HDAC class I and class II B. It has a regulatory effect on the abnormal epigenetic function of tumors. By inhibiting the related HDAC subtypes to increase the acetylation level of chromatin histone, chromatin remodeling is initiated, which changes the gene expression of multiple signal transduction pathways (i.e. epigenetic changes), thereby inhibiting the cell cycle of tumors, inducing apoptosis of tumors, and having overall regulatory activity on cellular immunity. Induction and enhancement of natural killer cells (NK) and antigen-specific cytotoxic T cells (CTL) mediated tumor killing. Chidamide can also enhance the mechanism of dendritic cells presenting and maturing tumor antigens, inhibiting regulatory T cells (Treg) and MDSC cells, and promote the anti-tumor immune function through regulating the micro-environment of tumor immunosuppression.
Because of the poor prognosis of advanced soft tissue sarcoma, there is no standard treatment for second-line treatment. Therefore, we think it is necessary to explore the feasibility of combination of chidamide and Toripalimab in advanced, refractory and progressive soft tissue sarcoma after failure of standard treatment, and look forward to further improving the efficacy of soft tissue sarcoma.
- Conditions
- Sarcoma
- Being tested
- chidamide and toripalimab
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chidamide and toripalimabDrug
The eligible patients with advanced soft tissue sarcoma were treated with chidamide combined with toripalimb. Chidamide 30mg orally twice a week;
Toripalimab 240 mg (fixed dose) every three weeks.
Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment.
| Study group | Role | What they receive |
|---|---|---|
| chidamide combined with Toripalimab | Experimental | chidamide 30mg orally twice a week;
240 mg of toripalimab (fixed dose) every three weeks.
Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment. Receives: Drug: chidamide and toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary outcomes (3)
Progress free survival
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: until Progressive Disease(PD) or death(up to 24 months)
Overall Survival
Overall survival is defined as the time until death due to any cause.
Measured: From randomization until death (up to 24 months)
Disease Control Rate
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: each 42 days up to intolerance the toxicity or PD (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 posted19 Jul 2019
- Study start19 Jan 2020
- Primary completion30 Oct 2025
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025931
- Sponsor's protocol ID
- SunYat-senU-chidamide
- Status last verified
- Dec 2023
- First submitted
- 17 Jul 2019
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multi-center, Open, Phase II Study of Chidamide Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04025931
- Acronym / sponsor ID
- SunYat-senU-chidamide
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Jan 2020 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 19 Jul 2019 (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.
Soft tissue sarcoma is a relatively rare malignant tumor with an incidence of about 1-2/100,000. The best way to obtain evidence-based medical evidence is to participate in clinical trials with new drugs (especially targeted drugs and immunotherapy). Chidamide, an oral subtype-selective histone deacetylase inhibitor monotherapy was effective on the patients with hematological tumors by inhibiting HDAC activity and other ways, showing good anti-tumor activity. Histone deacetylase inhibitors (HDACi) may also reverse drug resistance or inefficiency of immunoassay inhibitors, and combination therapy has shown preliminary efficacy in a variety of tumors.Because of the poor prognosis of advanced soft tissue sarcoma, there is no standard second-line treatment. Therefore, we think it is necessary to explore the feasibility of combination of chidamide and Toripalimab monoclonal antibody in advanced, refractory and progressive soft tissue sarcoma after failure of standard treatment, and look forward to further improving the efficacy of soft tissue sarcoma.
Detailed description
Histone deacetylase inhibitor (HDACI) can inhibit many kinds of hematological tumors by inhibiting HDAC activity and other ways, showing good anti-tumor activity. Chidamide is a new chemical structure benzamide HDAC inhibitor developed independently in China. It has the selectivity of HDAC subtypes and unique efficacy. In a phase II clinical study of Chidamide in the treatment of peripheral T-cell lymphoma in China in 2009, 79 patients with recurrent or refractory lymphoma had ORR of 27.9%. The 2016 edition of the Chinese Expert Consensus on Chidamide in the Treatment of PTCL discussed in detail the treatment of Chidamide alone or in combination with other drugs.
The representative drug of immunological checkpoint inhibitors is programmed death 1 (PD-1/PD-L1). PD-1/PD-L1 immunotherapy activates the body's own immune system to attack cancer cells by blocking the PD-1/PD-L1 pathway with drugs. Immunotherapy show its long-term control of cancer and its effectiveness in a variety of cancers.
In a multicenter phase II clinical trial, 80 patients with bone and soft tissue sarcoma were treated with single drug of PD-1 antibody Pembrolizumab. The results showed that all the patients with soft tissue sarcoma achieved therapeutic effect were undifferentiated pleomorphic sarcoma and liposarcoma. The overall objective remission rate was 18% (7/40), suggesting that Pembrolizumab alone does not fully activate suppressed T cells, and may need to be combined to improve the efficacy.
Recent studies have shown that combination of epigenetic regulators, such as histone deacetylase inhibitors (HDACi), can overcome some major drug resistance constraints and ensure patient safety. Pre-clinical data based on mouse models strongly support the feasibility and effectiveness of combination therapy. In vitro and in vivo studies, combined use of pan- or class I selective HDACi can benefit further. Chidamide is mainly targeted at subtypes 1, 2, 3 and 10 of HDAC class I and class II B. It has a regulatory effect on the abnormal epigenetic function of tumors. By inhibiting the related HDAC subtypes to increase the acetylation level of chromatin histone, chromatin remodeling is initiated, which changes the gene expression of multiple signal transduction pathways (i.e. epigenetic changes), thereby inhibiting the cell cycle of tumors, inducing apoptosis of tumors, and having overall regulatory activity on cellular immunity. Induction and enhancement of natural killer cells (NK) and antigen-specific cytotoxic T cells (CTL) mediated tumor killing. Chidamide can also enhance the mechanism of dendritic cells presenting and maturing tumor antigens, inhibiting regulatory T cells (Treg) and MDSC cells, and promote the anti-tumor immune function through regulating the micro-environment of tumor immunosuppression.
Because of the poor prognosis of advanced soft tissue sarcoma, there is no standard treatment for second-line treatment. Therefore, we think it is necessary to explore the feasibility of combination of chidamide and Toripalimab in advanced, refractory and progressive soft tissue sarcoma after failure of standard treatment, and look forward to further improving the efficacy of soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chidamide combined with Toripalimab | Experimental | Drug: chidamide and toripalimabchidamide 30mg orally twice a week; 240 mg of toripalimab (fixed dose) every three weeks. Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patients voluntarily participated in this study and signed the informed consent;
- The pathology diagnosed with at least one measurable lesion according to RECIST 1.1 standard. The pathology includes synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, dermatofibrosareoma promberans, ewing's sarcoma /primary neural ectoderm tumors, desmoplastic small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma. Except for chondrosarcoma, osteosarcoma, malignant mesothelioma, alveolar soft tissue sarcoma, gastrointestinal stromal tumor;
- Advanced sarcoma patients with refractory or distant metastasis after failure of first-line standard therapy;
- 14 ~ 70 years old; ECOG PS score: 0~1; Expected survival beyond 3 months;
- Adequate organ and bone marrow function, no serious hematopoietic dysfunction or heart, lung, liver, kidney, thyroid dysfunction and immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other medical support was received within 14 days before the use of the research drug):
Key exclusion criteria (18 listed)
- Patients who have previously used chidamide or other histone deacetylase inhibitors;
- Previous treatment with immunological checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);
- Other malignancies that have occurred or are present at the same time within 5 years, except for cured cancers including carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Start the study of systemic anti-cancer therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer).
- The patients received Chinese herbal medicine or Chinese patent medicine treatment within 7 days before the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chidamide and toripalimabThe eligible patients with advanced soft tissue sarcoma were treated with chidamide combined with toripalimb. Chidamide 30mg orally twice a week; Toripalimab 240 mg (fixed dose) every three weeks. Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment. | Drug | chidamide combined with Toripalimab |
Primary outcome
Objective Response Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
3 secondary outcomes
Progress free survival
Time frame: until Progressive Disease(PD) or death(up to 24 months)
Overall Survival
Time frame: From randomization until death (up to 24 months)
Disease Control Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 chidamide and toripalimab in people with Sarcoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 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: finished, as of the sponsor's last update on 12 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)). 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 12 Jun 2026.