NCT03368651 The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
| NCT ID | NCT03368651 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2016-01-01 |
| Primary Completion | 2026-11-30 |
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 230 participants in total. It began in 2016-01-01 with a primary completion date of 2026-11-30.
⚠ 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
To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.
Eligibility Criteria
Inclusion Criteria: * older than 18 years old and younger than 75 years; * ECOG PS≤1; * proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; * not previous treated for tumor; * estimated tumor and tumor thrombosis could be removed en bloc in operation; * 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; Exclusion Criteria: * cannot tolerate TAI or surgery; * distant metastasis exits; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03368651 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 NCT03368651 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 230 participants.
Is NCT03368651 currently recruiting?
Yes, NCT03368651 is actively recruiting participants. Contact the research team at lishaoh@sysucc.org.cn for enrollment information.
Where is the NCT03368651 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT03368651 clinical trial?
NCT03368651 is sponsored by Sun Yat-sen University. The trial plans to enroll 230 participants.
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