Study on High Dose Melphalan Treatment Directly to the Liver for Metastatic Colorectal Cancer with Liver-Dominant Disease
Sponsor: Delcath Systems Inc.
ClinicalTrials ID:NCT06607458
This clinical trial is testing whether a high dose of chemotherapy given directly to the liver, followed by standard cancer treatment, is safe and effective for patients with colorectal cancer that has spread mainly to the liver. The study will compare this approach to using standard cancer treatment alone.
Patient Parameters
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Program Overview
The aim of this study is to find out if a liver-targeted high dose chemotherapy treatment, followed by standard cancer therapy, is safe and can effectively treat colorectal cancer that has spread to the liver. Researchers will compare this method to using only the standard cancer treatment. Participants will either receive the liver-directed chemotherapy followed by standard treatment or just the standard treatment alone. They will visit the clinic every two weeks for checkups and tests, and have scans every two months to monitor their progress.
Description
This study involves patients with colorectal cancer that has spread mainly to the liver. Participants will be randomly assigned to one of two groups. One group will receive a high dose of chemotherapy directly to the liver, followed by standard cancer treatment with trifluridine-tipiracil and bevacizumab. The other group will receive only the standard cancer treatment.
The study will include about 90 patients, with 60 receiving the liver-directed treatment and 30 receiving only the standard treatment. The liver-directed chemotherapy will be given in two cycles, with the second cycle occurring 8 to 10 weeks after the first, depending on recovery from any side effects. Tumor response will be checked every 8 weeks during the liver-directed treatment.
Both groups will continue with the standard treatment until the cancer progresses, the patient experiences intolerable side effects, or the study ends. There will be no switching between the two groups.
Safety will be closely monitored through regular checkups, lab tests, and physical exams. An independent board will review patient safety data throughout the study.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with metastatic colorectal cancer that has spread mainly to the liver, with liver tumors making up the majority of the cancer.
- Liver tumors must be measurable by CT or MRI scans.
- If cancer has spread outside the liver, it must be limited and not life-threatening compared to the liver disease.
- Previous treatments with certain chemotherapy and biological therapies must have been tried and either not worked or caused intolerable side effects.
- Good overall health with an ECOG performance status of 0 or 1.
- Scans to confirm eligibility must be done within 28 days before starting the study.
Exclusion Criteria
- Severe liver disease or significant liver damage.
- Serious heart conditions or recent heart attacks.
- Severe lung disease that prevents the use of general anesthesia.
- Bleeding disorders or brain abnormalities that increase bleeding risk.
- Active second cancer or recent treatment for another invasive cancer.
- Use of immunosuppressive drugs or inability to stop blood thinners temporarily.
- Active infections, including Hepatitis B or C.
- Severe allergic reactions to iodine contrast or study drugs.
- Uncontrolled diabetes or thyroid disorders.
- Recent anti-cancer therapy or investigational drug use.
- Previous treatment with trifluridine-tipiracil or allergic reactions to similar drugs.
- Known allergies to bevacizumab or similar products.
- Conditions that contraindicate the use of bevacizumab, such as uncontrolled high blood pressure or recent blood clots.
- Previous liver-directed treatments like chemoembolization or radioembolization.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| The University of Kansas Clinical Research Center | 66205 | Fairway | Kansas |
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