TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to … (NCT06071052) | Clinical Trial Compass
CompletedPhase 2
TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens
China21 participantsStarted 2023-12-01
Plain-language summary
Liver metastasis is the main reason that affects the survival rates of patients with colorectal cancer (CRLM), and is also the main cause of death of those patients. Especially after the failure of first-line or second-line system treatment, the prognosis of those patients is extremely poor, with the median OS of only 3.5 months. Even in combination with molecular targeted drugs such as cetuximab or bevacizumab, the median tumor-free survival period is only 4.8-6.8 months, and OS is only 11-15 months. When they have disease progression, treatment is currently a difficult clinical problem. Regofinib is a new targeted drug for the third-line treatment of advanced colorectal cancer in recent years. However, in the prospective multicenter clinical study, compared with the placebo group, the extended OS is only 1.4 months, which is not so satisfactory. How to improve the survival of these advanced patients with drug resistance is an important clinical problem to be solved urgently. Minimally invasive local treatment may be a promising way to solve this problem. Transcatheter arterial chemoembolization (TACE) and hepatic artery infusion chemotherapy (HAIC) are currently the most widely used methods in clinical practice. In theory, TACE combined with HAIC can control small metastasis and embolic residual lesions. The combination of TACE and HAIC can improve the curative effect. Whether the combination of TACE, HAIC and Regofinib can be expected to achieve the effect of 1+1+1\>3 in CRLM patients who have failed the previous second-line chemotherapy remains unknown. Therefore, the purpose of this study is to explore the safety and clinical efficacy of irinotecan-loaded drug-eluting beads-TACE (DEBIRI-TACE) combined with HAIC and Regofinib in the treatment of patients with CRLM who failed standard treatment regimens.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 18-75 years old, gender unlimited;
. Patients with liver metastasis of colorectal cancer by pathological histology or clinical diagnosis (refer to the Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastasis of Colorectal Cancer, 2016 Edition), those who were mainly exposed to liver metastasis with large tumor load and suffered from no clear extrahepatic metastasis;
. Patients with a liver area tumor no more than 5 tumor nodules, and a nodule size no more than10cm;
. Patients subject to the failure of previous chemotherapy regimen containing irinotecan or oxaliplatin after at least six cycles of systemic chemotherapy; they cannot undergo surgery or refuse surgery;
. Patients with liver tumor who did not receive interventional treatment (TACE, ablation, iodine particle treatment, etc.) within one year;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate, ORR
Timeframe: through study completion, an average of 1 year
2
Time to progression, TTP
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT06071052
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
. Patients with an expected survival period longer than 3 months;
. Patients with favorable liver function (7 points for Child-Pugh A or B);
. Patients with a physical fitness ECOG no more than one point;
Exclusion criteria
. Patients with distant metastases except the liver;
. Patients subject to the treatment of TACE, ablation or iodine particles within one year;
. Patients with obvious artero / venous fistula and cancer plugs in the main portal vein;
. Patients who had suffered from or were currently developing other malignant tumors (except for the cured basal or squamous cell skin carcinoma or cervical carcinoma in situ);
. Patients whose white blood cells were less than 3,000 cell / mm3, or platelet count less than 50,000 / mm3;
. Patients subject to renal insufficiency (creatinine\> 2 mg/L);
. Patients whose AST and / or ALT was / were more than 5 times the upper limit of normal;
. Patients with poor coagulation function, an INR larger than 1.5, or currently subject to anticoagulant therapy or known hemorrhagic disease;