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 range18 Years – 75 Years

SexALL

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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;
✓. 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

What they're measuring

Objective response rate, ORR

Timeframe: through study completion, an average of 1 year

Time to progression, TTP

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06071052

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Liver Metastasis Colon Cancer trials