Combining TACE with immune therapy for liver cancer treatment
Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
This study is testing if combining a liver cancer treatment called TACE with immune therapy can help people with hard-to-treat liver tumors feel better and improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06487663 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of transarterial chemoembolization (TACE) combined with immune checkpoint inhibitors (ICI) for patients with unresectable liver malignant tumors, including hepatocellular carcinoma and cholangiocarcinoma. The TACE procedure involves delivering chemotherapy directly to the liver tumors through microcatheters, followed by the administration of ICIs to enhance the immune response against the cancer. Patients will undergo repeated evaluations based on specific imaging criteria to assess treatment response. The study aims to optimize treatment schedules to maximize patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of unresectable hepatocellular carcinoma or cholangiocarcinoma who have not received prior systemic therapy.
Not a fit: Patients with significant cardiovascular diseases, evidence of extrahepatic spread, or those who have previously received immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced liver cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of TACE and immune checkpoint inhibitors, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of HCC by histology/ cytology or clinical criteria * Sign informed consent * When screening for age, the age should be ≥ 18 years old * Eligible for TACE treatment * ECOG physical condition score is 0 or 1 * No prior systemic therapy for HCC, especially immunotherapy * According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation Exclusion Criteria: * Have any history of kidney disease or nephrotic syndrome * Evidence of extrahepatic spread (EHS) * Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control * Any condition representing a contraindication to TACE as determined by the investigators * Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding * Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment) * Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization) * Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.
Where this trial is running
Tianjin
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Haipeng Yu
- Email: jieruke@163.com
- Phone: 022-23340123
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.