Colorectal Cancer MetastaticPhase 2LIVERPEARLNCT04595266
Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease
A Phase 2 study testing FOLFOX regimen, Anti-EGFR or Bevacizumab and LIVERPEARLS-Irinotecan in people with Colorectal Cancer Metastatic and Liver Metastasis Colon Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 8 sites in Spain.
Trial summary
Non-commercial, prospective, randomized, multicenter, national, phase II, open-label comparative clinical trial. The patients will be randomized in a 1: 1 ratio in two arms: Control arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab Experimental arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Liver Metastasis Colon Cancer
- What is being tested?
- FOLFOX regimen, Anti-EGFR or Bevacizumab and LIVERPEARLS-Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesSpain
- Study dates
- 29 Jun 2021to Jan 2026
- 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 aged ≥ 18 years.
- Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size> 5 cm. Patients with a diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable.
- Measurable disease following RECIST version 1.1 criteria
- Adequate bone marrow function, according to:
- Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study
- Platelet count ≥ 100 x 109 / L
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- Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L
- Adequate liver function, according to:
- Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases
- Adequate renal function, with creatinine levels <1.5 mg / dL. Blood Ureic Nitrogen (BUN)> 50 ml / min.
- Albumin> 3.0 g / dL
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Patients capable of understanding the information and giving their written informed consent to participate in the study
- Women of childbearing potential must commit to sexual abstinence or use of barrier contraceptive methods during the study and must have a negative pregnancy test.
Who cannot join
- Extension of the disease> 50% of the liver parenchyma (evaluated by CT performed within the month prior to inclusion)
- Previous chemotherapy treatment for metastatic colorectal cancer
- Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before inclusion in the trial), myocardial infarction (≤ 6 months before inclusion in the trial), unstable angina, uncontrolled hypertension, congestive heart failure of New York Heart Association (NYHA) grade II or higher or severe cardiac arrhythmia.
- History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
- Altered coagulation (Quick> 50%)
- Patients with active infectious processes
Show all 11Show fewer
- Patients with any of the contraindications specified in the technical data sheet of the study drug or with allergies to some of the drugs used
- Pregnant or lactating patients
- Portal thrombosis
- Severe portal hypertension
- Extrahepatic metastases
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Clínic
Barcelona, Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
H. Univ. Ramón y Cajal
Madrid, Madrid, 28044
Hospital Universitario 12 de Octubre
Madrid, Madrid
Hospital Universitario La Paz
Madrid, Madrid
Complejo Hospitalario de Navarra
Pamplona, Pamplona
Hospital Parc Taulí
Sabadell, Barcelona
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
About this study
Official title: Randomized, Multicenter Phase II Study of Monoclonal FOLFOX6m + mAb Alone or in Combination With Liver Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease Limited to the Liver With Poor Prognosis
Non-commercial, prospective, randomized, multicenter, national, phase II, open-label comparative clinical trial.
The patients will be randomized in a 1: 1 ratio in two arms:
Read more
Control arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab Experimental arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab + Intra-arterial liver chemotherapy with LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded with 100 mg of irinotecan in both liver lobes) cycles 2 and 4.
The main objective is to evaluate the radiological objective response rate according to the RECIST version 1.1 criteria at 6 months. Secondary objectives include: Evaluate overall survival, progression-free survival (PFS), safety profile, hepatic PFS, R0 liver surgery rate.
Read the detailed description
Hepatic intra-arterial therapy (TACE) with irinotecan has been used in several prospective studies demonstrating an acceptable toxicity profile. Two randomized phase II studies have evaluated the efficacy of TACE with irinotecan compared to conventional chemotherapy in metastatic colon cancer. A second-line treatment study demonstrated an increase in PFS in the TACE versus FOLFIRI treatment arm.
A prospective open, randomized, multicenter phase II study is proposed that will include patients with liver metastases of colorectal origin with poor prognostic criteria.
LIFEPEARLS® is a CE marked medical device consisting of microspheres for use in chemoembolization. The device uses 100 +/- 50 micron microspheres of hydrogel into which chemotherapeutic agents are loaded and delivered into the hepatic artery to treat liver tumors. This device allows the continuous release of irinotecan in liver tumors causing a specific necrosis. The penetration of irinotecan into the tumor tissue is deeper thanks to the microspheres, avoiding proximal occlusion of the vessels supplying the tumor.
Systemic treatment will be administered according to the usual guidelines:
-FOLFOX6m for 6 months + monoclonal Ab (cycles are repeated every 15 days) Premedication: Dexamethasone 20 mg IV + ondansetron 8mg IV
The dose of FOLFOX will be:
Leucovorin: 400 mg / m2 IV over 15 minutes on day 1 of each cycle. Fluorouracil (5-FU): 400mg / m2 IV bolus (15 min) followed by continuous IV infusion for 46 h of 2,400 mg / m2 on day 1 of each cycle.
Oxaliplatin 85 mg / m2 IV over 120 minutes on cycle day 1. In case of RAS wt colorectal cancer administer anti-EGFR together with FOLFOX6m, and in case of mutated RAS colorectal cancer administer Bevacizumab together with FOLFOX6m.
In the combination arm of systemic chemotherapy with IRINOPEARL, in the 2nd and 4th cycles, chemotherapy will be replaced by treatment with hepatic chemoembolization with IRINOPEARL.
The disease will be evaluated by CT or MRI at baseline and every 12 weeks until progression according to RECIST 1.1 criteria.
- Being tested
- FOLFOX regimen, Anti-EGFR or Bevacizumab, LIVERPEARLS-Irinotecan
- Keywords
- Colorectal cancer, Chemoembolization, LIVERPEARLS-Irinotecan, Liver metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
Also called Leucovorin/Fluorouracil/Oxaliplatin
Leucovorin: 400 mg / m2 IV over 15 minutes on day 1 of each cycle. Fluorouracil (5-FU): 400mg / m2 IV bolus (15 min) followed by continuous IV infusion for 46 h of 2,400 mg / m2 on day 1 of each cycle.
Oxaliplatin 85 mg / m2 IV over 120 minutes on cycle day 1
Anti-EGFR or BevacizumabBiological
Also called monoclonal antibody anti EGFR (RASwt) or Bevacizumab (RASmut)
In case of RAS wt colorectal cancer administer anti-EGFR together with FOLFOX6m, and in case of mutated RAS colorectal cancer administer Bevacizumab together with FOLFOX6m.
Treatment administered following Summary of medicinal Product Characteristics (SmPC) approved indications.
LIVERPEARLS-IrinotecanDrug
Also called Chemoembolization of Irinotecan in hydrogel microspheres
Chemoembolization of Irinotecan in 100 +/- 50 micron hydrogel microspheres. Irinotecan will be loaded at a dose of 100 mg. LIFEPEARLS® is a CE marked medical device consisting of microspheres for use in chemoembolization. This device allows the continuous release of irinotecan in liver tumors causing a specific necrosis. The penetration of irinotecan into the tumor tissue is deeper thanks to the microspheres, avoiding proximal occlusion of the vessels supplying the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Systemic chemotherapy with FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab). Receives: Drug: FOLFOX regimen; Biological: Anti-EGFR or Bevacizumab |
| Experimental | Experimental | Systemic chemotherapy with FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab) + Intra-arterial liver chemotherapy with LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded with 100 mg of irinotecan in both liver lobes) cycles 2 and 4. Receives: Drug: FOLFOX regimen; Biological: Anti-EGFR or Bevacizumab; Drug: LIVERPEARLS-Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients with tumor size reduction according to RECIST 1.1 criteria at 6 months
Measured: Evaluated at 6 months after first investigation drug administration.
Secondary outcomes (5)
Overall Survival (OS)
Time from randomization until death from any cause. Patients still alive at the last contact or lost to follow-up will be censored.
Measured: Through study completion, average 2 years
Progression free survival
Time from from the date of randomization to the date of first documented disease progression according to RECIST 1.1 criteria or the date of death due to any cause. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression.
Measured: Through study completion, average 2 years. Evaluated during a total of 2 years (estimated) by CT scan or MR every 12 weeks
Frequency of adverse events
Percentage of adverse events, laboratory alterations and treatment discontinuations observed in both treatment arms classified by type and severity (Safety)
Measured: Through study completion, average 2 years
Hepatic Progression free survival
Time from from the date of randomization to the date of first documented disease progression within the liver according to RECIST 1.1 criteria or the date of death due to any cause. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression.
Measured: Through study completion, average 2 years. Evaluated during a total of 2 years (estimated) by CT scan or MR every 12 weeks
Proportion of patients with liver surgery
Proportion of patients undergoing R0 surgery for liver metastases
Measured: Through study completion, average 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start29 Jun 2021
- Primary completion15 Jan 2024
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1: 1 ratio in the 2 arms: Control Arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab Experimental Arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab + Intra-arterial liver chemotherapy with LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded with 100 mg of irinotecan in both liver lobes) cycles 2 and 4.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estela Pineda, M.D, Study chair, Hospital Clinic of BarcelonaDavid Páez, M.D., Ph.D., Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595266
- Sponsor's protocol ID
- GEMCAD-1802
- Other IDs
- 2020-003795-40
- Acronym
- LIVERPEARL
- Status last verified
- Sep 2025
- First submitted
- 6 Oct 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter Phase II Study of Monoclonal FOLFOX6m + mAb Alone or in Combination With Liver Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease Limited to the Liver With Poor Prognosis
- ClinicalTrials.gov ID
- NCT04595266
- Acronym / sponsor ID
- LIVERPEARL / GEMCAD-1802
- Keywords
- Colorectal cancer, Chemoembolization, LIVERPEARLS-Irinotecan, Liver metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer DigestivoUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Oct 2020 (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.
Non-commercial, prospective, randomized, multicenter, national, phase II, open-label comparative clinical trial.
The patients will be randomized in a 1: 1 ratio in two arms:
Control arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab Experimental arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab + Intra-arterial liver chemotherapy with LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded with 100 mg of irinotecan in both liver lobes) cycles 2 and 4.
The main objective is to evaluate the radiological objective response rate according to the RECIST version 1.1 criteria at 6 months. Secondary objectives include: Evaluate overall survival, progression-free survival (PFS), safety profile, hepatic PFS, R0 liver surgery rate.
Detailed description
Hepatic intra-arterial therapy (TACE) with irinotecan has been used in several prospective studies demonstrating an acceptable toxicity profile. Two randomized phase II studies have evaluated the efficacy of TACE with irinotecan compared to conventional chemotherapy in metastatic colon cancer. A second-line treatment study demonstrated an increase in PFS in the TACE versus FOLFIRI treatment arm.
A prospective open, randomized, multicenter phase II study is proposed that will include patients with liver metastases of colorectal origin with poor prognostic criteria.
LIFEPEARLS® is a CE marked medical device consisting of microspheres for use in chemoembolization. The device uses 100 +/- 50 micron microspheres of hydrogel into which chemotherapeutic agents are loaded and delivered into the hepatic artery to treat liver tumors. This device allows the continuous release of irinotecan in liver tumors causing a specific necrosis. The penetration of irinotecan into the tumor tissue is deeper thanks to the microspheres, avoiding proximal occlusion of the vessels supplying the tumor.
Systemic treatment will be administered according to the usual guidelines:
-FOLFOX6m for 6 months + monoclonal Ab (cycles are repeated every 15 days) Premedication: Dexamethasone 20 mg IV + ondansetron 8mg IV
The dose of FOLFOX will be:
Leucovorin: 400 mg / m2 IV over 15 minutes on day 1 of each cycle. Fluorouracil (5-FU): 400mg / m2 IV bolus (15 min) followed by continuous IV infusion for 46 h of 2,400 mg / m2 on day 1 of each cycle.
Oxaliplatin 85 mg / m2 IV over 120 minutes on cycle day 1. In case of RAS wt colorectal cancer administer anti-EGFR together with FOLFOX6m, and in case of mutated RAS colorectal cancer administer Bevacizumab together with FOLFOX6m.
In the combination arm of systemic chemotherapy with IRINOPEARL, in the 2nd and 4th cycles, chemotherapy will be replaced by treatment with hepatic chemoembolization with IRINOPEARL.
The disease will be evaluated by CT or MRI at baseline and every 12 weeks until progression according to RECIST 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1: 1 ratio in the 2 arms: Control Arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab Experimental Arm. Systemic chemotherapy with FOLFOX6m + monoclonal Ab + Intra-arterial liver chemotherapy with LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded with 100 mg of irinotecan in both liver lobes) cycles 2 and 4.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: FOLFOX regimen, Biological: Anti-EGFR or BevacizumabSystemic chemotherapy with FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab). |
| Experimental | Experimental | Drug: FOLFOX regimen, Biological: Anti-EGFR or Bevacizumab, Drug: LIVERPEARLS-IrinotecanSystemic chemotherapy with FOLFOX6m + monoclonal Ab (anti-EGFR or bevacizumab) + Intra-arterial liver chemotherapy with LIFEPEARLS-IRINOTECAN (catheterization and infusion of 100 +/- 50 micron microspheres loaded with 100 mg of irinotecan in both liver lobes) cycles 2 and 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients aged ≥ 18 years.
- Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size> 5 cm. Patients with a diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable.
- Measurable disease following RECIST version 1.1 criteria
- Adequate bone marrow function, according to:
- Adequate liver function, according to:
Key exclusion criteria (11 listed)
- Extension of the disease> 50% of the liver parenchyma (evaluated by CT performed within the month prior to inclusion)
- Previous chemotherapy treatment for metastatic colorectal cancer
- Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before inclusion in the trial), myocardial infarction (≤ 6 months before inclusion in the trial), unstable angina, uncontrolled hypertension, congestive heart failure of New York Heart Association (NYHA) grade II or higher or severe cardiac arrhythmia.
- History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
- Altered coagulation (Quick> 50%)
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 |
|---|---|---|
| FOLFOX regimenAlso: Leucovorin/Fluorouracil/OxaliplatinLeucovorin: 400 mg / m2 IV over 15 minutes on day 1 of each cycle. Fluorouracil (5-FU): 400mg / m2 IV bolus (15 min) followed by continuous IV infusion for 46 h of 2,400 mg / m2 on day 1 of each cycle. Oxaliplatin 85 mg / m2 IV over 120 minutes on cycle day 1 | Drug | Control, Experimental |
| Anti-EGFR or BevacizumabAlso: monoclonal antibody anti EGFR (RASwt) or Bevacizumab (RASmut)In case of RAS wt colorectal cancer administer anti-EGFR together with FOLFOX6m, and in case of mutated RAS colorectal cancer administer Bevacizumab together with FOLFOX6m. Treatment administered following Summary of medicinal Product Characteristics (SmPC) approved indications. | Biological | Control, Experimental |
| LIVERPEARLS-IrinotecanAlso: Chemoembolization of Irinotecan in hydrogel microspheresChemoembolization of Irinotecan in 100 +/- 50 micron hydrogel microspheres. Irinotecan will be loaded at a dose of 100 mg. LIFEPEARLS® is a CE marked medical device consisting of microspheres for use in chemoembolization. This device allows the continuous release of irinotecan in liver tumors causing a specific necrosis. The penetration of irinotecan into the tumor tissue is deeper thanks to the microspheres, avoiding proximal occlusion of the vessels supplying the tumor. | Drug | Experimental |
Primary outcome
Objective response rate (ORR)
Time frame: Evaluated at 6 months after first investigation drug administration.
The proportion of patients with tumor size reduction according to RECIST 1.1 criteria at 6 months
5 secondary outcomes
Overall Survival (OS)
Time frame: Through study completion, average 2 years
Progression free survival
Time frame: Through study completion, average 2 years. Evaluated during a total of 2 years (estimated) by CT scan or MR every 12 weeks
Frequency of adverse events
Time frame: Through study completion, average 2 years
Hepatic Progression free survival
Time frame: Through study completion, average 2 years. Evaluated during a total of 2 years (estimated) by CT scan or MR every 12 weeks
Proportion of patients with liver surgery
Time frame: Through study completion, average 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 29 Sep 2025.
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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.
Estela Pineda, M.D study chair
Hospital Clinic of Barcelona
David Páez, M.D., Ph.D. study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX regimen, Anti-EGFR or Bevacizumab and LIVERPEARLS-Irinotecan in people with Colorectal Cancer Metastatic and Liver Metastasis Colon Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 8 sites in Spain.
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 16 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
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 (ORR) (time frame: Evaluated at 6 months after first investigation drug administration.). 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 29 Sep 2025.