Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
Recruiting now · Phase 3
Conditions studied: Hepatocellular Carcinoma, Liver Transplantation
In brief
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.
Key facts
- Study ID
- NCT04595864
- Run by
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- People needed
- 40
- Starts
- 2020-11-01
- Expected to finish
- 2026-10-30
- Last updated by the study team
- 2021-11-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- older than 18 years old and younger than 75 years listed for liver transplant;
- ECOG PS≤1;
- Child-Pugh Stage A or B
- Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- Not previous treated for tumor;
- The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT
- No distant metastasis;
- The lab test could meet:
- Neutrophil count≥2.0×109/L; Hemoglobin≥100g/L; Platelet count≥75×109/L; Serum albumin≥35g/L; Total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; Serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
- Sign up consent.
You may not qualify if…
- Cannot tolerate TAI or LT;
- Distant metastasis exits;
- Known history of other malignancy;
- Be allergic to related drugs;
- Be treated before (interferon included);
- Known history of HIV infection;
- Known history of drug or alcohol abuse;
- Have GI hemorrhage or cardiac/brain vascular events within 30 days;
- Pregnancy.
Where it is running
- Nanjing Drum tower hospital — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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