NCT06311929RecruitingPhase 4
Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma
VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study
Source: ClinicalTrials.gov · Last updated 7 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 9 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chen Xiaoping
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06311929
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- From 1 Apr 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active infection.
Lab values
- 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.).
- Other significant clinical and laboratory abnormalities that affect the safety evaluation.
Other
- Pregnant and lactating women.
- Inability to follow the study protocol for treatment or follow up as scheduled.
Who the study is looking for
- Aged 18-75.
- No previous local or systemic treatment for hepatocellular carcinoma.
- Child-Pugh liver function score ≤ 7.
- ECOG PS 0-1.
- No serious organic diseases of the heart, lungs, brain, kidneys, etc.
- Pathologic type is hepatocellular carcinoma.
- Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.