RecruitingPhase 3NCT04595864

Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

40 participants

Start Date

Nov 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. Milan (solitary tumour \<5cm, or up to 3 tumours, each \<3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none \>4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of \>70% and recurrence rate ranging from 5-15% can be achieved. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria,and qualify for LT. This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving chemotherapy directly into the artery supplying the liver (called transarterial chemoinfusion or TAI) before a liver transplant can help people with liver cancer (hepatocellular carcinoma) whose tumors are too large to normally qualify for transplant. The aim is to shrink the tumors enough to make transplant safer and more successful. **You may be eligible if...** - You are between 18 and 75 years old and on the liver transplant waiting list - You have confirmed hepatocellular carcinoma (liver cancer) that is beyond the standard size criteria for transplant (Milan or UCSF criteria) - You have not received any prior treatment for your liver cancer - There is no spread to other organs - Your liver function and blood counts are within acceptable ranges **You may NOT be eligible if...** - You cannot tolerate the arterial infusion procedure or liver transplant surgery - Your cancer has spread to distant organs - You have another active cancer - You have HIV, significant drug or alcohol abuse - You have had recent serious bleeding or a stroke/heart attack within 30 days - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTransarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

TAI


Locations(1)

Nanjing Drum tower hospital

Nanjing, Jiangsu, China

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NCT04595864


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