NCT04595864 Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
| NCT ID | NCT04595864 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2020-11-01 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. older than 18 years old and younger than 75 years listed for liver transplant; 2. ECOG PS≤1; 3. Child-Pugh Stage A or B 4. Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; 5. Not previous treated for tumor; 6. The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT 7. No distant metastasis; 8. 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; 9. Sign up consent. Exclusion Criteria: 1. Cannot tolerate TAI or LT; 2. Distant metastasis exits; 3. Known history of other malignancy; 4. Be allergic to related drugs; 5. Be treated before (interferon included); 6. Known history of HIV infection; 7. Known history of drug or alcohol abuse; 8. Have GI hemorrhage or cardiac/brain vascular events within 30 days; 9. Pregnancy.
Contact & Investigator
Beicheng Sun, PhD，MD
STUDY CHAIR
Nanjing University
Frequently Asked Questions
Who can join the NCT04595864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04595864 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT04595864 currently recruiting?
Yes, NCT04595864 is actively recruiting participants. Contact the research team at drzhangwj@163.com for enrollment information.
Where is the NCT04595864 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT04595864 clinical trial?
NCT04595864 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Beicheng Sun, PhD，MD at Nanjing University. The trial plans to enroll 40 participants.
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