Using Regorafenib with TACE for Advanced Liver Cancer Treatment
Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University · NCT05811481
This study is testing whether adding a treatment called TACE to regorafenib can help people with advanced liver cancer who haven't responded to earlier treatments feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University (other) |
| Drugs / interventions | chemotherapy, regofinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05811481 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of regorafenib alone versus its combination with transcatheter arterial chemoembolization (TACE) in patients with advanced hepatocellular carcinoma who have previously failed first-line therapy. It will evaluate the safety and prognostic imaging factors associated with regorafenib in this context. The study will also explore the necessity of incorporating TACE into second-line treatment for advanced liver cancer. Patients will be monitored for treatment outcomes and side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced hepatocellular carcinoma who have failed first-line systemic treatment and have measurable liver lesions.
Not a fit: Patients with other types of liver cancer or those who have received certain prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with advanced hepatocellular carcinoma.
How similar studies have performed: While there have been studies on regorafenib and TACE separately, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic recurrence before (including a); ( - ) Previous failure of first-line systemic treatment; ( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At least one measurable lesion in the liver. Exclusion Criteria: ( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy, radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the second-line systemic treatment, I also received local treatment, systemic chemotherapy, radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to any drug included in the study; ( - ) Pregnant or lactating women;
Where this trial is running
Guangzhou, Guangdong
- FirstSunYetSen — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: WenBo Guo
- Email: patrickguo2008@163.com
- Phone: +8613922282028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Transcatheter Arterial ChEmoembolization, Regorafenib