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Tests treatment safety and results for Refractory Metastatic Colorectal Cancer
Official title 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
ClinicalTrials.gov ID: NCT06607458
What this study is testing
What is Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab?
Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab is an investigational medicine, being studied as a potential treatment for refractory metastatic colorectal cancer.
Also referred to as Melphalan, HDS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or less...
- Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tumor burden is located in the liver, and the liver...
- Disease in the liver must be measurable (per RECIST v.1.1 guidelines) by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- If there is evidence of extrahepatic metastatic disease, it is limited, and the life-threatening component of disease is in the liver. Limited...
- Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to...
You likely can't join if
- Child-Pugh Class B or C cirrhosis or evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large...
- New York Heart Association functional classification II, III or IV or active cardiac condition(s), including unstable coronary syndromes (unstable or...
- History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
- History of bleeding disorders, presence of brain metastases, or other intracranial abnormalities found on baseline radiologic imaging that would put...
- Known varices at risk of bleeding, including medium or large esophageal or gastric varices, active peptic ulcer, or history of recent hemoptysis.
- Active second malignancy, or has history of recently definitively treated invasive cancer in the past 2 years prior to enrolment with the exception...
See the full eligibility criteria
- Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or less of the liver parenchyma.
- Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tumor burden is located in the liver, and the liver lesions are not resectable or treatable with ablation or are...
- Disease in the liver must be measurable (per RECIST v.1.1 guidelines) by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- If there is evidence of extrahepatic metastatic disease, it is limited, and the life-threatening component of disease is in the liver. Limited extrahepatic disease is defined in this protocol as follows: up to 5 tumor...
- Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization.
- Previous treatment and progressed on or following, or intolerant to, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and/or an anti-EGFR therapy if RAS wild-type.
- ECOG PS of 0-1 within 14 days prior to randomization.
- 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...
- History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
- History of bleeding disorders, presence of brain metastases, or other intracranial abnormalities found on baseline radiologic imaging that would put them at risk for bleeding with anti-coagulation.
- Known varices at risk of bleeding, including medium or large esophageal or gastric varices, active peptic ulcer, or history of recent hemoptysis.
- Active second malignancy, or has history of recently definitively treated invasive cancer in the past 2 years prior to enrolment with the exception of non-melanoma skin cancer.
- Peritoneal lesions or large abdominal masses.
- Use of immunosuppressive drugs.
- Inability to temporarily stop chronic anti-coagulation therapy.
- Active bacterial infections with systemic manifestations.
- Active viral infection, including Hepatitis B and Hepatitis C infection. NOTE: Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are allowed...
- Severe allergic reaction to iodine contrast that cannot be controlled by premedication with antihistamines and steroids.
- History of or known hypersensitivity to melphalan or the components of the melphalan/HDS system.
- History of known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
- Uncontrolled endocrine disorder including diabetes mellitus, hypothyroidism, or hyperthyroidism.
- Received anti-cancer therapy including radiotherapy or investigational agent for any indication ≤ 30 days prior to randomization
- Previous treatment with trifluridine-tipiracil.
- History of allergic reactions attributed to compounds of similar composition to trifluridine/tipiracil or any of its excipients.
- Hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
- History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- Contraindications to bevacizumab, including uncontrolled hypertension, history of active fistula or bowel perforation (unless in the setting of a resected primary), history of CVA or arterial thrombotic event in the...
- Evidence of hepatic vein or portal vein thrombosis
- Prior chemoembolization or radioembolization to the liver or prior hepatic arterial infusion therapy
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Santa Monica, California, United States
- Tampa, Florida, United States
- Fairway, Kansas, United States
- New Orleans, Louisiana, United States
- Salt Lake City, Utah, United States
- Prague, Czechia
- Hanover, Germany
- Leipzig, Germany
- Milan, Italy
- Leiden, Netherlands
- Belgrade, Serbia
- Barcelona, Spain
- Izmir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Santa Monica, California, United States; Tampa, Florida, United States; Fairway, Kansas, United States; New Orleans, Louisiana, United States; Salt Lake City, Utah, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.