NCT06311929 Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma
| NCT ID | NCT06311929 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chen Xiaoping |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-12-31 |
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 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2024-04-01 with a primary completion date of 2027-12-31.
⚠ 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
Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. How to improve the prognosis of this group of patients is an urgent issue to be addressed.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-75. 2. No previous local or systemic treatment for hepatocellular carcinoma. 3. Child-Pugh liver function score ≤ 7. 4. ECOG PS 0-1. 5. No serious organic diseases of the heart, lungs, brain, kidneys, etc. 6. Pathologic type is hepatocellular carcinoma. 7. Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining. Exclusion Criteria: 1. Pregnant and lactating women. 2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.). 3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator. 4. Active infection. 5. Other significant clinical and laboratory abnormalities that affect the safety evaluation. 6. Inability to follow the study protocol for treatment or follow up as scheduled.
Contact & Investigator
Xiaoping Chen
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT06311929 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HCC. 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 NCT06311929 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06311929 currently recruiting?
Yes, NCT06311929 is actively recruiting participants. Contact the research team at wgzhang@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT06311929 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06311929 clinical trial?
NCT06311929 is sponsored by Chen Xiaoping. The principal investigator is Xiaoping Chen at Tongji Hospital. The trial plans to enroll 300 participants.