OncoMatch/Clinical Trials/NCT06607458
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease
Is NCT06607458 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab and Trifluridine-tipiracil plus Bevacizumab Alone for refractory metastatic colorectal cancer.
Treatment: Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab · Trifluridine-tipiracil plus Bevacizumab Alone — The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone. Participants will: * Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone * Visit clinic at least every two weeks for checkups and tests * Complete scans approximately every two months
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Required: NRAS wild-type
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine-based chemotherapy
Previous treatment and progressed on or following, or intolerant to, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Must have received: oxaliplatin-based chemotherapy
Previous treatment and progressed on or following, or intolerant to, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Must have received: irinotecan-based chemotherapy
Previous treatment and progressed on or following, or intolerant to, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Must have received: anti-VEGF biological therapy
Previous treatment and progressed on or following, or intolerant to, ... an anti-VEGF biological therapy
Must have received: anti-EGFR therapy
Previous treatment and progressed on or following, or intolerant to, ... and/or an anti-EGFR therapy if RAS wild-type
Cannot have received: trifluridine-tipiracil (trifluridine-tipiracil)
Previous treatment with trifluridine-tipiracil
Cannot have received: chemoembolization
Prior chemoembolization ... to the liver
Cannot have received: radioembolization
Prior ... radioembolization to the liver
Cannot have received: hepatic arterial infusion therapy
prior hepatic arterial infusion therapy
Lab requirements
Liver function
Child-Pugh Class B or C cirrhosis or evidence of clinically significant portal hypertension excluded
Cardiac function
NYHA functional classification II, III or IV or active cardiac condition(s) excluded
Child-Pugh Class B or C cirrhosis or evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large abdominal varices, prior history of varices by endoscopy). New York Heart Association functional classification II, III or IV or active cardiac condition(s), including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease that create(s) undue risks of undergoing general anesthesia.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- UCLA Hematology/Oncology-Santa Monica · Santa Monica, California
- Moffitt Cancer Center · Tampa, Florida
- The University of Kansas Clinical Research Center · Fairway, Kansas
- Huntsman Cancer Institute, University of Utah · Salt Lake City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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