Colorectal Cancer MetastaticPhase 2HAITINCT06332079
Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients
A Phase 2 study testing 166Holmium TARE, Cetuximab and Panitumumab in people with Colorectal Cancer Metastatic, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.
Trial summary
The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- 166Holmium TARE, Cetuximab and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2024to 16 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent to study procedures;
- Age ≥18 years;
- Histologically proven diagnosis of colorectal adenocarcinoma, with or without primary tumour in situ;
- Liver-only disease at radiological exams involving less than 50% of liver volume;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2;
- Patients with partial response or stable disease according to RECIST 1.1 criteria deemed unresectable after 6-12 cycles of induction first-line chemotherapy;
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- Life expectancy of at least 12 weeks;
- Hematopoietic function: absolute neutrophil count ≥ 1,500/mm3; platelet count
- ≥100,000/mm3; haemoglobin level ≥ 9 g/dL;
- Liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN); alkaline phosphatase
- ≤ 5 times ULN; AST ≤ 5 times ULN;
- Renal function: creatinine clearance > 50 mL/min or serum creatinine 1.5 x UNL; no renal disease that would preclude study treatment or follow-up;
- Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;
- Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as outlined in Section 7.5 - Contraception, starting during study screening visit throughout the study period up to 180 days after the last dose of chemotherapy Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
- Will and ability to comply with the protocol
- RAS/BRAF wild-type and left sided primary tumor
- First-line induction chemotherapy regimen permitted up to 6-12 cycles with:
- FOLFOX or FOLFIRI + anti-EGFR (cetuximab or panitumumab). Patients who interrupted anti-EGFR target therapy during induction phase due to toxicity or other reasons, candidate to maintenance with fluoropyridine alone therapy can be enrolled.
- RAS mutated and/or right-sided primary tumor
- First-line induction chemotherapy regimen admitted up to 6-12 cycles with:
- FOLFOX/FOLFIRI/XELOX + bevacizumab or FOLFOXIRI + bevacizumab. Patients who interrupted bevacizumab during induction phase due to toxicity or other reasons, candidate to maintenance with fluoropyridine alone therapy can be enrolled.
Who cannot join
- Patients with radiological evidence of extra liver distant metastases.
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis, or any other contraindications to radioembolization treatment;
- Previous radiotherapy delivered to the liver;
- Patients with BRAF mutated and/or MSI-high tumours;
- Previous history of malignancy within the last 5 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
- Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer);
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- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating study procedures and treatment administration Clinically significant (e.g. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication
- Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 180 days after the last trial treatment;
- History of a previous allergic reaction to contrast media that would preclude safe angiography of the hepatic arteries, in the opinion of the treating Interventional Radiologist;
- Known hypersensitivity to fluoropyrimidine, anti-VEGF or anti-EGFR MoAb.
- Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation;
- Withdrawal of the consent to take part to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Evaluating Holmium-166 TARE Followed by Maintenance Therapy in Liver Limited Unresectable Colorectal Cancer Patients After First-line Chemotherapy and Target Agents
The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively.
Read the detailed description
HAITI is a phase II, single-arm trial of 166Ho-TARE followed by maintenance therapy in liver-limited unresectable colorectal cancer patients, achieving partial response or stable disease according to RECIST 1.1 criteria after 6-12 cycles of induction first-line chemotherapy.
Two cohorts of patients are included:
- left sided RAS/BRAF wild-type (cohort A)
- right-sided and/or RAS mutated (cohort B)
Enrolled patients will be treated with different maintenance therapy according to study cohort (fluoropyrimidine + anti-EGFR or bevacizumab).
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- 166Holmium TARE, Cetuximab, Panitumumab, 5-Fluorouracil, Bevacizumab
- Keywords
- HOLMIUM, TARE, Maintenance therapy, Liver-limited colorectal cancer, Unresectable colorectal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
166Holmium TAREProcedure or surgery
166Ho-TARE treatment comprises of two hospital visits: one for a work-up procedure and another for the therapy procedure, with usually a 1-2 weeks interval.
CetuximabDrug
Target agent
PanitumumabDrug
Target agent
5-FluorouracilDrug
Chemotherapy
BevacizumabDrug
Target agent
CapecitabineDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| COHORT A/B | Experimental | Eligible patients will receive Scout dose procedure. After 1-2 weeks, patients eligible for radioembolization will receive 166Ho-TARE and at least after 3 weeks, maintenance treatment with fluoropyrimidine plus target agents (anti-EGFR or bevacizumab) according to the respective study cohort.
Maintenance treatment:
Cohort A:
* CETUXIMAB iv day1, over 1 hours, 500 mg/sqm or PANITUMUMAB iv over 1 hours, 6 mg/kg, every 14 days
* LED 200 mg/sqm iv over 1 hour, day 1
* 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment
Cohort B:
* BEVACIZUMAB 5 mg/kg iv biweekly day1, over 30 minutes
* LED 200 mg/sqm iv over 1 hour, day 1
* 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment
CAPECITABINE, 1000 mg/sqm orally twice daily, day 1-14, plus bevacizumab 7,5 mg/kg iv every 21 days is allowed. Receives: Procedure: 166Holmium TARE; Drug: Cetuximab; Drug: Panitumumab; Drug: 5-Fluorouracil; Drug: Bevacizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) Rate
PFS is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis.
Measured: 36 months
Secondary outcomes (9)
Overall Toxicity rate
Overall Toxicity rate is defined as the percentage of patients, relative to the total of enrolled subjects, who receive 166Ho-TARE and at least one cycle of chemotherapy, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0) during the study treatment.
Measured: 36 months
Grade 3/ Grade 4 Toxicity rate
Grade 3/ Grade 4 Toxicity rate is defined as the percentage of patients, relative to the total of enrolled subjects, who receive 166Ho-TARE and at least one cycle of chemotherapy, experiencing a specific adverse event of severity grade 3/ grade 4, according to National Cancer Institute Common Toxicity Criteria (version 5.0) during the study treatment.
Measured: 36 months
Post-treatment Disease Control Rate (DCR)
Post-treatment DCR, is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR), partial (PR) response or stable disease (SD), according to RECIST 1.1 criteria, during the study treatment. The determination of clinical response will be based on investigator reported measurements. Tumor re-assessment with CT scan will be repeated every 8- weeks.
Measured: 36 months
Progression free survival
Progression free survival (PFS), is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis.
Measured: 36 months
Overall Survival
Overall Survival (OS), is defined as the time from enrolment to death from any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
Measured: 36 months
Dose-response relationships
Dose-response relationships are defined as the relationships between the tumor-absorbed doses calculated on post-treatment SPECT-CT (dependent variables) and the following independent variables: tumor response (SD, PR, CR according to RECIST CRITERIA v 1.1), progression free survival rate, and Overall Survival.
Measured: 36 months
Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire
The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice.
QoL assessed using the EORTC QLQ-CR29 questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics.
Measured: 36 months
Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire
The EORTC QLQ-CR30 is 30-item instrument designed to measure quality of life in all cancer patients.
QoL assessed using the EORTC QLQ-CR30 questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics.
Measured: 36 months
Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire
The EuroQol EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
QoL assessed using the EuroQol EQ-5D questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start13 Mar 2024
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Why it stopped: Medical devices (QuiremScout/QuiremSpheres) no longer available due to discontinuation of production by the manufacturer
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
- Not applicable
- Intervention model
- Single group
- Model description
- Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab). A total of 23 patients will be enrolled in each cohort.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluca Masi, MD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332079
- Sponsor's protocol ID
- HAITI 2023-505356-22-00
- Acronym
- HAITI
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Holmium-166 TARE Followed by Maintenance Therapy in Liver Limited Unresectable Colorectal Cancer Patients After First-line Chemotherapy and Target Agents
- ClinicalTrials.gov ID
- NCT06332079
- Acronym / sponsor ID
- HAITI / HAITI 2023-505356-22-00
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- HOLMIUM, TARE, Maintenance therapy, Liver-limited colorectal cancer, Unresectable colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medical devices (QuiremScout/QuiremSpheres) no longer available due to discontinuation of production by the manufacturer
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 27 Mar 2024 (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.
The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively.
Detailed description
HAITI is a phase II, single-arm trial of 166Ho-TARE followed by maintenance therapy in liver-limited unresectable colorectal cancer patients, achieving partial response or stable disease according to RECIST 1.1 criteria after 6-12 cycles of induction first-line chemotherapy.
Two cohorts of patients are included:
- left sided RAS/BRAF wild-type (cohort A)
- right-sided and/or RAS mutated (cohort B)
Enrolled patients will be treated with different maintenance therapy according to study cohort (fluoropyrimidine + anti-EGFR or bevacizumab).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab). A total of 23 patients will be enrolled in each cohort.
| Arm | Type | Receives |
|---|---|---|
| COHORT A/B | Experimental | Procedure: 166Holmium TARE, Drug: Cetuximab, Drug: Panitumumab, Drug: 5-Fluorouracil, Drug: Bevacizumab, Drug: CapecitabineEligible patients will receive Scout dose procedure. After 1-2 weeks, patients eligible for radioembolization will receive 166Ho-TARE and at least after 3 weeks, maintenance treatment with fluoropyrimidine plus target agents (anti-EGFR or bevacizumab) according to the respective study cohort. Maintenance treatment: Cohort A: * CETUXIMAB iv day1, over 1 hours, 500 mg/sqm or PANITUMUMAB iv over 1 hours, 6 mg/kg, every 14 days * LED 200 mg/sqm iv over 1 hour, day 1 * 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment Cohort B: * BEVACIZUMAB 5 mg/kg iv biweekly day1, over 30 minutes * LED 200 mg/sqm iv over 1 hour, day 1 * 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment CAPECITABINE, 1000 mg/sqm orally twice daily, day 1-14, plus bevacizumab 7,5 mg/kg iv every 21 days is allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written informed consent to study procedures;
- Age ≥18 years;
- Histologically proven diagnosis of colorectal adenocarcinoma, with or without primary tumour in situ;
- Liver-only disease at radiological exams involving less than 50% of liver volume;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2;
Key exclusion criteria (12 listed)
- Patients with radiological evidence of extra liver distant metastases.
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis, or any other contraindications to radioembolization treatment;
- Previous radiotherapy delivered to the liver;
- Patients with BRAF mutated and/or MSI-high tumours;
- Previous history of malignancy within the last 5 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
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 |
|---|---|---|
| 166Holmium TARE166Ho-TARE treatment comprises of two hospital visits: one for a work-up procedure and another for the therapy procedure, with usually a 1-2 weeks interval. | Procedure or surgery | COHORT A/B |
| CetuximabTarget agent | Drug | COHORT A/B |
| PanitumumabTarget agent | Drug | COHORT A/B |
| 5-FluorouracilChemotherapy | Drug | COHORT A/B |
| BevacizumabTarget agent | Drug | COHORT A/B |
| CapecitabineChemotherapy | Drug | COHORT A/B |
Primary outcome
Progression-free survival (PFS) Rate
Time frame: 36 months
PFS is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis.
9 secondary outcomes
Overall Toxicity rate
Time frame: 36 months
Grade 3/ Grade 4 Toxicity rate
Time frame: 36 months
Post-treatment Disease Control Rate (DCR)
Time frame: 36 months
Progression free survival
Time frame: 36 months
Overall Survival
Time frame: 36 months
Dose-response relationships
Time frame: 36 months
Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire
Time frame: 36 months
Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire
Time frame: 36 months
Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Medical devices (QuiremScout/QuiremSpheres) no longer available due to discontinuation of production by the manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Gianluca Masi, MD principal investigator
Azienda Ospedaliero, Universitaria Pisana
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 166Holmium TARE, Cetuximab and Panitumumab in people with Colorectal Cancer Metastatic, run by Gruppo Oncologico del Nord-Ovest at 1 site in Italy.
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 21 inclusion and 12 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 was stopped early (reason given: Medical devices (QuiremScout/QuiremSpheres) no longer available due to discontinuation of production by the manufacturer). 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?
Progression-free survival (PFS) Rate (time frame: 36 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 5 Jan 2026.