Actively Recruiting
Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2021-11-05
40
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 18 years and younger than 75 years and listed for liver transplant
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 1 or less
- Child-Pugh liver function stage A or B
- Confirmed hepatocellular carcinoma by pathology or standard diagnostic criteria
- No prior treatment for tumor
- Tumor diagnosed beyond Milan or University of San Francisco criteria for liver transplantation
- No distant metastasis
- Laboratory tests meeting specified blood counts and liver and kidney function limits
- Signed informed consent
You will not qualify if you...
- Unable to tolerate transarterial chemoinfusion or liver transplantation
- Presence of distant metastasis
- History of other cancers
- Allergy to related chemotherapy drugs
- Prior treatment including interferon
- Known HIV infection
- History of drug or alcohol abuse
- Gastrointestinal bleeding or heart/brain vascular events within 30 days
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Drum tower hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
W
Wenjie Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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