MetastasesPhase 1NCT05195710
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
A Phase 1 study testing Yttrium-90 (Y-90) resin microspheres in people with Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases
- What is being tested?
- Yttrium-90 (Y-90) resin microspheres
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 31 Mar 2028
- Phase
- Phase 1
- 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
- Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team
- Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart
- Received at least four cycles (or two months) of chemotherapy
- Willing, able and mentally competent to provide written informed consent
- Medically and physically operable as determined by the surgeon
Who cannot join
- Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist
- Projected sFLR before Y-90 of <20% (starting with sFLR that is unrealistic for improvement to ≥30%)
- Performance status limitations (Karnofsky <80%, ECOG >1)
- Portal hypertension and/or cirrhosis
- Starting total bilirubin >1.3 mg/dL (except if patient has Gilbert's Disease)
- CEA >200 after 4 cycles of chemotherapy upon restaging visit
Show all 13Show fewer
- Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection
- Platelet count <100,000/µL
- Albumin <3.5 g/dl
- Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
- Pregnant or breast-feeding patient
- Other medical or clinical contraindications to liver surgery
- Non-English-speaking participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Ching-Wei David Tzeng, MD
Ching-Wei David Tzeng, MD
About this study
A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
Read the detailed description
Primary Objective:
To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Secondary Objectives:
- To describe changes in liver volume after Y-90 TARE, including:
- The kinetic growth rate (KGR) of the FLR
- Degree of hypertrophy 6 weeks after TARE
- Atrophy of targeted right hemi-liver from TARE date to date of surgery
- To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE
- To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM
- To assess measures of disease control, including:
- Tumor marker trend
- RECIST/mRECIST criteria
- CT morphologic response
- PET CT response
- To describe Patient Reported Outcomes using MDASI-GI
- To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively
- To describe dosimetry of individual liver lesions - using SPECT/CT, CT, and pathology correlation
- To describe change in liver function measured by the pre- and post-TARE HIDA SPECT/CT scans and hepatic function blood tests
- Conditions
- Metastases
- Being tested
- Yttrium-90 (Y-90) resin microspheres
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 (Y-90) resin microspheresDrug
Given by scan
| Study group | Role | What they receive |
|---|---|---|
| Yttrium-90 | Experimental | Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows. Receives: Drug: Yttrium-90 (Y-90) resin microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Measured: through study completion, an average of 1 year
The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start16 Nov 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor
- Investigators
- Ching-Wei Tzeng, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195710
- Sponsor's protocol ID
- 2021-0521
- Other IDs
- NCI-2021-13239
- Status last verified
- May 2026
- First submitted
- 24 Nov 2021
- Last updated
- 26 May 2026
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT05195710
- Acronym / sponsor ID
- 2021-0521
- Conditions
- Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 19 Jan 2022 (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.
A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
Detailed description
Primary Objective:
To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Secondary Objectives:
- To describe changes in liver volume after Y-90 TARE, including:
- The kinetic growth rate (KGR) of the FLR
- Degree of hypertrophy 6 weeks after TARE
- Atrophy of targeted right hemi-liver from TARE date to date of surgery
- To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE
- To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM
- To assess measures of disease control, including:
- Tumor marker trend
- RECIST/mRECIST criteria
- CT morphologic response
- PET CT response
- To describe Patient Reported Outcomes using MDASI-GI
- To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively
- To describe dosimetry of individual liver lesions - using SPECT/CT, CT, and pathology correlation
- To describe change in liver function measured by the pre- and post-TARE HIDA SPECT/CT scans and hepatic function blood tests
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium-90 | Experimental | Drug: Yttrium-90 (Y-90) resin microspheresHelp to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team
- Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart
- Received at least four cycles (or two months) of chemotherapy
- Willing, able and mentally competent to provide written informed consent
- Medically and physically operable as determined by the surgeon
Key exclusion criteria (13 listed)
- Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist
- Projected sFLR before Y-90 of <20% (starting with sFLR that is unrealistic for improvement to ≥30%)
- Performance status limitations (Karnofsky <80%, ECOG >1)
- Portal hypertension and/or cirrhosis
- Starting total bilirubin >1.3 mg/dL (except if patient has Gilbert's Disease)
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 |
|---|---|---|
| Yttrium-90 (Y-90) resin microspheresGiven by scan | Drug | Yttrium-90 |
Primary outcome
The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Time frame: through study completion, an average of 1 year
The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Time frame: through study completion, an average of 1 year
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 26 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Ching-Wei Tzeng, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Yttrium-90 (Y-90) resin microspheres in people with Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
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 5 inclusion and 13 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 26 May 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ching-Wei Tzeng, MD ((713) 792-0386, cdtzeng@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.