Combining radioembolization with FTD-TPI and bevacizumab for advanced colorectal cancer
Single-arm, Phase II Trial of Trifluridine/Tipiracil (FTD-TPI), Bevacizumab, and Individualized Radioembolization With 166Ho-microspheres in Refractory Metastatic Colorectal Cancer
This study is testing if a new combination of a targeted radiation treatment and two medications can help people with advanced colorectal cancer who haven't responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06563986 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety, tolerability, and effectiveness of individualized radioembolization using 166Holmium microspheres in combination with the systemic treatments trifluridine/tipiracil (FTD-TPI) and bevacizumab for patients with refractory metastatic colorectal cancer. The aim is to assess whether this combination can improve disease control and overall survival in patients who have not responded to standard therapies. Participants will receive both the radioembolization treatment and the systemic medications as part of their care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable liver dominant metastatic colorectal cancer who have previously shown disease progression or intolerance to standard treatments.
Not a fit: Patients with resectable liver disease or those who have not received prior therapies for metastatic colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that enhances disease control and survival for patients with advanced colorectal cancer.
How similar studies have performed: While the combination of these treatments is innovative, similar approaches in radioembolization have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unresectable liver dominant mCRC * Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the treatment of metastatic colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen * Patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be eligible to enter the study. * Patients who refuse oxaliplatin or irinotecan will also be eligible to enter the study. * Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy count the adjuvant therapy as treatment of metastatic colorectal cancer. * Written informed consent * Age \>=18 years * Estimated hepatic tumor replacement ≥ 10% and ≤ 50% of total liver volume Eastern Cooperative Oncology Group performance status 0-1 * Adequate organ function as measured by: WBC ≥ 3.0 x 109/L, platelets ≥ 100 x 109/L, absolute neutrophil count \> 1.5 x 109/L, Hemoglobin (Hb) \> 5 mmol/L (\>8.1 g/dL), eGFR ≥ 35 ml/min, Serum transaminases (AST \& ALT) ≤ 5 x upper limit of normal (ULN), Total bilirubin ≤ ULN, Albumin \> 3 g/dL * At least one measurable liver lesion according to the PERCIST 1.0 Exclusion Criteria: * Significant extrahepatic disease, defined as symptomatic extrahepatic disease, more than 10 pulmonary nodules (maximum diameter of each lung metastasis \<20mm), and/or peritoneal carcinomatosis. * Eligible for ablative local treatment of liver metastases (e.g. surgical resection, ablation) * Lung shunt \>20 Gy, as calculated using scout dose SPECT/CT * Absorbed tumor dose \<90 Gy when dosing at a maximum average absorbed normal liver dose * Other malignancy confounding prognosis * Receipt of chemotherapy within 28 days prior to study treatment * Previous or current treatment with radioembolization * Major surgery within 28 days or incompletely healed surgical incision before starting study therapy * Any serious comorbidity preventing the safe administration of anti-VEGF antibody treatment. This includes uncontrolled hypertension or treatment with ≥3 antihypertensive drugs, arterial (cerebro)vascular event within the past 6 months, history of severe bleeding, history of GI perforation, or presence of fistulae * Any serious and/or chronic liver disease preventing the safe administration of radio- embolization * Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes and gallbladder is accepted * Pregnancy or breastfeeding * Body weight over 150 kg (because of maximum table load) * Known severe allergy for intravenous contrast fluids * Participation to another investigational study which may compromise any endpoint of the study
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Guus Bol, dr.
- Email: G.M.Bol-2@umcutrecht.nl
- Phone: +31 88 75 652 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.