Colorectal Cancer MetastaticPhase 1iRE-CNCT04108481

Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

A Phase 1 study testing Durvalumab and Yttrium-90 RadioEmbolization in people with Colorectal Cancer Metastatic and Colon Cancer, run by University of Iowa at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal cancer (mCRC), which… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Colorectal Cancer Metastatic, Colon Cancer, Metastatic Colorectal Cancer
What is being tested?: Durvalumab and Yttrium-90 RadioEmbolization
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2020to 17 Nov 2023
Phase: Phase 1
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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years
Histological or cytological confirmation of colorectal cancer with metastasis to the liver. Mismatch repair or microsatellite instability status of the tumor needs to be known. Tumors need to be mismatch repair proficient (for mismatch repair deficient tumors immunotherapy is already approved).
Patient must have at least 1 liver lesion measurable as defined in the protocol
Must have liver metastases and be appropriate for treatment with Y-90 radioembolization therapy as determined by the treating medical oncologist and interventional radiologist/oncologist, and nuclear medicine physician(s). NOTE: the goal of therapy is safety and parenchymal sparing. Typically, since the treatment is personalized, the goal is to have at least 30% liver parenchymal sparing post treatment.
Must have a metastatic focus amendable to biopsy. It is permissible to use same or alternative lesion for biopsy for assessment for tumor response and changes in microenvironment (mandatory pre- and post-Y90-RE biopsy).
At least 2 but no more than 3 lines of therapy allowed in metastatic setting. These include at least treatment with a fluoropyrimidine, oxaliplatin, and/or irinotecan-based therapy, an anti-VEGF therapy and, if RAS wild-type, an anti-EGFR therapy, unless deemed intolerant or not suitable by the treating oncologist. NOTE: adjuvant and/or maintenance chemotherapy does not count as an additional line of therapy. (Patients with more than 3 lines of therapy are at risk for liver disease from prior systemic therapies and would not be reasonable candidates for Y90-RE).

Show all 16Show fewer

ECOG Performance Status (PS) 0 or 1.
Negative serum pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only.
Females of childbearing potential (FOCBP), must use appropriate method(s) of contraception. FOCBP are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Additionally, FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab (13 weeks) plus 30 days (duration of ovulatory cycle) for a total of 17 weeks post-treatment completion (details in appendix).
Men who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab plus 90 days (duration of sperm turnover) for a total of 25 weeks post-treatment completion (details in appendix).
Provide written informed consent.
Ability to complete questionnaire(s) by themselves or with assistance.
Willingness to provide mandatory blood specimens for correlative research (detailed in protocol).
Willingness to provide mandatory tissue specimens for correlative research (detailed in protocol). NOTE: If tissue is deemed inaccessible, patient cannot participate in study.
Willingness to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
Must have a life expectancy of at least 6 months.

Who cannot join

Any of the following laboratory abnormalities:
Hemoglobin <8.0 g/dL
Absolute neutrophil count (ANC) <1500/mm3
Platelet count <100,000/mm3
Total bilirubin >1.5 x ULN (except in subjects with Gilbert Syndrome, who cannot have a total bilirubin > 3.0 mg/dL)
Alanine aminotransferase (ALT) and Aspartate transaminase (AST) >2.5 x ULN

Show all 29Show fewer

Serum creatinine > 1.5 x ULN OR
Calculated creatinine clearance <30 ml/min using the Cockcroft-Gault formula
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic infections, or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease). NOTE: Patients with previously treated CNS metastases that are radiographically and neurologically stable for ≥ 6 weeks are permitted.
Uncontrolled intercurrent illness including, but not limited to, autoimmune disease, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. EXCEPTION: Patients who have adequately controlled autoimmune disease with or without medications are permitted as long as deemed reasonable by treating physician.
Received any other investigational agent incorporating chemotherapy and/or biologics within 14 days prior to first dose of durvalumab which would be considered as a treatment for the primary neoplasm. For patients on active treatment, last treatment and 1st dose of Durvalumab should be at least ≥ 14 days. EXCEPTION: Other forms of concurrent observational studies are permitted.
Other active malignancy ≤3 years prior to registration. EXCEPTIONS: Non-melanoma skin cancer, lentigo maligna- in-situ, or carcinoma-in-situ of the cervix. Also prior malignancy already treated with curative intent and with no known active disease present would be considered eligible.
History of unstable cardiac disease defined as one of the following:
Congestive heart failure > class II New York Heart Association (NYHA). (Appendix II)
Unstable angina (angina symptoms at rest) or new onset angina (began ≤ 3 months prior to registration)
Myocardial infarction ≤ 3 months
Uncontrolled cardiac ventricular arrhythmias. EXCEPTION: Subjects that are stable on anti-arrhythmic therapy are eligible.
Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 14 days of first dose of durvalumab. NOTE: Subjects can be screened during washout period.
History of severe allergic reactions (i.e. Grade 4 allergy, anaphylactic reaction from which the subject did not recover ≤ 6 hours of initiation of supportive care)
Failure to recover from toxicities from prior anti-cancer therapy, defined as having not resolved to National Cancer Institute (NCI) CTCAE version 5.0 Grade ≤ 1. EXCEPTIONS: Alopecia and laboratory values listed per the exclusion criteria. Also subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any investigational products (i.e. hearing loss) will be permitted.
Use of steroids. EXCEPTIONS: Systemic glucocorticoids will be permitted as long as it is ≤20 mg of prednisone equivalent. Topical steroids, such as bronchodilators and local steroid injections are also permitted if clinically required.
Patients with renal failure currently requiring dialysis of any kind.
Patients weighing <30kg will be excluded from enrollment
History of allogenic organ transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Immunotherapy Combined With Yttrium-90 RadioEmbolization in the Treatment of Colorectal Cancer With Liver Metastases [iRE-C - Clinical Trial]

Read the detailed description

The purpose of this clinical trial is to find out more about the side effects of immunotherapy with a form of radiation treatment for the cancer in the liver called Yttrium-90 RadioEmbolization (Y90-RE). An immunotherapy drug, durvalumab, will be given intravenously every 2 weeks. Investigators are studying what doses of durvalumab are safe for people in combination with this form of radiation treatment. Patients in this study will receive durvalumab, which is experimental and not approved by the U.S. Food and Drug Administration (FDA) for metastatic colorectal cancer. Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver.

The number of doses of the immunotherapy drug (range: 2 to 5) will depend on the cohort patients are assigned to. There is no placebo. Everyone on the study is treated with immunotherapy alongside Y90-RadioEmbolization.

Conditions: Colorectal Cancer Metastatic, Colon Cancer, Metastatic Colorectal Cancer, Rectal Cancer, Liver Metastasis Colon Cancer, Colo-rectal Cancer
Being tested: Durvalumab, Yttrium-90 RadioEmbolization
Keywords: Y90, Y90-RE, Radioembolization, Y90-Radioembolization, y-90, Yttrium, Yttrium-90, Microsatellite Stable, MSS, CRC, mCRC, Colorectal, Liver Metastases, Liver Metastasis, Durvalumab, Anti-PD1, Anti-PDL1, Immunotherapy, Colorectal Cancer, Mismatch repair proficient
Medical subject headings: Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Also called IMFINZI, MEDI4736, MEDI-4736, Anti-PDL1
Immunotherapy
Yttrium-90 RadioEmbolizationRadiation
Also called Y90-RE, Y90, Glass Microspheres, yttrium90
Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver

Study groups in NCT04108481
Study group	Role	What they receive
Y90-RE in combination with immunotherapy (durvalumab)	Experimental	The treatment phase starts of with the immunotherapy drug (durvalumab) - "priming doses" every 2 weeks prior to patient getting mapped and ready for treatment with Y90-RadioEmbolization. Post-Y90-RE, treatment is approximately 2 months in combination with fixed doses (750 mg) of durvalumab. The number and timing of doses of durvalumab each patient will receive will depend on the dose level the patient is assigned to (range 2-5 doses of immunotherapy). A single patient will be treated per dose level until the first dose limiting toxicity (DLT) is recorded. Once the first DLT is recorded, two additional patients are treated at the same dose level and the trial reverts to a standard 3+3 design. Up to 6 patients will be treated at each dose level. The maximum tolerated dose (MTD) will be defined as the highest dose level for which at most 1 out of 6 patients experience a DLT. Receives: Drug: Durvalumab; Radiation: Yttrium-90 RadioEmbolization

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC)
MTD will be defined as the highest dose level for which at most 1 out of 6 patients experience a dose-limiting toxicity (DLT) using CTCAE version 5.0.
Measured: Initiation of treatment up to 8 weeks and 2 doses ("priming") of immunotherapy prior to Y90-RE.

Secondary outcomes (7)

Incidence of adverse events (AE) per CTCAE version 5.0
The number and severity of all adverse events (overall, by dose-level, and by tumor molecular subtype) will be tabulated and summarized.
Measured: Initiation of screening up to 2 years
Determine overall response rate (ORR)
Overall response rate is defined as the proportion of evaluable patients that have achieved a complete response (CR) or partial response (PR) by RECIST v1.1 as well as mRECIST and iRECIST.
Measured: Up to 2 months post treatment
Determine the disease control rate (DCR)
Disease control rate is defined as the proportion of evaluable patients that have achieved a complete response (CR), partial response (PR), or stable disease (SD) by RECIST v1.1 as well as mRECIST and iRECIST.
Measured: Up to 2 months post treatment
Determine liver-specific progression free survival
Progression free survival is defined as the proportion of evaluable patients that have achieved liver-specific progression free survival (Liver-PFS)
Measured: Up to 2 months post treatment
Determine overall progression free survival
Progression free survival is defined as the proportion of evaluable patients that have achieved overall progression free survival (PFS)
Measured: Up to 2 years
Determine overall survival
Overall survival (OS) is defined as the time from randomization to death of any cause.
Measured: Up to 2 years
Determine duration of response
Duration of response (DOR) is defined as the time measurement criteria for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202017 Nov 2023

First posted30 Sep 2019
Study start5 Oct 2020
Primary completion17 Nov 2023
Study completion17 Nov 2023

Why it stopped: DSMC-directed closure

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.
More trials run by University of IowaThe 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
Model description: Accelerated titration design with an expansion phase once MTD is determined to treat up to a total of 18 patients.
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04108481
Sponsor's protocol ID: 201909709
Acronym: iRE-C
Status last verified: Mar 2025
First submitted: 25 Sep 2019
Last updated: 28 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC

All Colorectal Cancer Metastatic trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunotherapy Combined With Yttrium-90 RadioEmbolization in the Treatment of Colorectal Cancer With Liver Metastases [iRE-C - Clinical Trial]
ClinicalTrials.gov ID: NCT04108481
Acronym / sponsor ID: iRE-C / 201909709
Conditions: Colorectal Cancer Metastatic, Colon Cancer, Metastatic Colorectal Cancer, Rectal Cancer, Liver Metastasis Colon Cancer, Colo-rectal Cancer
Keywords: Y90, Y90-RE, Radioembolization, Y90-Radioembolization, y-90, Yttrium, Yttrium-90, Microsatellite Stable
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: DSMC-directed closure
Enrolment: 5 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Collaborators: Biocompatibles UK Ltd, AstraZeneca
Study start: 5 Oct 2020 (actual)
Primary completion: 17 Nov 2023 (actual)
Study completion: 17 Nov 2023 (actual)
First posted: 30 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Accelerated titration design with an expansion phase once MTD is determined to treat up to a total of 18 patients.

Arm	Type	Receives
Y90-RE in combination with immunotherapy (durvalumab)	Experimental	Drug: Durvalumab, Radiation: Yttrium-90 RadioEmbolizationThe treatment phase starts of with the immunotherapy drug (durvalumab) - "priming doses" every 2 weeks prior to patient getting mapped and ready for treatment with Y90-RadioEmbolization. Post-Y90-RE, treatment is approximately 2 months in combination with fixed doses (750 mg) of durvalumab. The number and timing of doses of durvalumab each patient will receive will depend on the dose level the patient is assigned to (range 2-5 doses of immunotherapy). A single patient will be treated per dose level until the first dose limiting toxicity (DLT) is recorded. Once the first DLT is recorded, two additional patients are treated at the same dose level and the trial reverts to a standard 3+3 design. Up to 6 patients will be treated at each dose level. The maximum tolerated dose (MTD) will be defined as the highest dose level for which at most 1 out of 6 patients experience a DLT.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Age ≥18 years
Histological or cytological confirmation of colorectal cancer with metastasis to the liver. Mismatch repair or microsatellite instability status of the tumor needs to be known. Tumors need to be mismatch repair proficient (for mismatch repair deficient tumors immunotherapy is already approved).
Patient must have at least 1 liver lesion measurable as defined in the protocol
Must have liver metastases and be appropriate for treatment with Y-90 radioembolization therapy as determined by the treating medical oncologist and interventional radiologist/oncologist, and nuclear medicine physician(s). NOTE: the goal of therapy is safety and parenchymal sparing. Typically, since the treatment is personalized, the goal is to have at least 30% liver parenchymal sparing post treatment.
Must have a metastatic focus amendable to biopsy. It is permissible to use same or alternative lesion for biopsy for assessment for tumor response and changes in microenvironment (mandatory pre- and post-Y90-RE biopsy).

Key exclusion criteria (29 listed)

Any of the following laboratory abnormalities:
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Co-morbid systemic infections, or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease). NOTE: Patients with previously treated CNS metastases that are radiographically and neurologically stable for ≥ 6 weeks are permitted.
Uncontrolled intercurrent illness including, but not limited to, autoimmune disease, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. EXCEPTION: Patients who have adequately controlled autoimmune disease with or without medications are permitted as long as deemed reasonable by treating physician.

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
DurvalumabAlso: IMFINZI, MEDI4736, MEDI-4736, Anti-PDL1Immunotherapy	Drug	Y90-RE in combination with immunotherapy (durvalumab)
Yttrium-90 RadioEmbolizationAlso: Y90-RE, Y90, Glass Microspheres, yttrium90Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver	Radiation	Y90-RE in combination with immunotherapy (durvalumab)

Primary outcome

Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC)
Time frame: Initiation of treatment up to 8 weeks and 2 doses ("priming") of immunotherapy prior to Y90-RE.
MTD will be defined as the highest dose level for which at most 1 out of 6 patients experience a dose-limiting toxicity (DLT) using CTCAE version 5.0.

7 secondary outcomes

Incidence of adverse events (AE) per CTCAE version 5.0
Time frame: Initiation of screening up to 2 years
Determine overall response rate (ORR)
Time frame: Up to 2 months post treatment
Determine the disease control rate (DCR)
Time frame: Up to 2 months post treatment
Determine liver-specific progression free survival
Time frame: Up to 2 months post treatment
Determine overall progression free survival
Time frame: Up to 2 years
Determine overall survival
Time frame: Up to 2 years
Determine duration of response
Time frame: Up to 2 years

Results and safety

The study was stopped early (reason given: DSMC-directed closure). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Colorectal Cancer Metastatic

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC

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.

Chandrikha Chandrasekharan, MD principal investigator

University of Iowa

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 Durvalumab and Yttrium-90 RadioEmbolization in people with Colorectal Cancer Metastatic and Colon Cancer, run by University of Iowa 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 16 inclusion and 29 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: stopped early, as of the sponsor's last update on 28 Mar 2025. 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?

The study was stopped early (reason given: DSMC-directed closure). Results are not available in the source record.

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?

Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC) (time frame: Initiation of treatment up to 8 weeks and 2 doses ("priming") of immunotherapy prior to Y90-RE.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04108481.

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 28 Mar 2025.