Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 monoclonal antibody and lenvatinib, PD-1 monoclonal antibody.
- Who it may be relevant to
- Registry conditions: HCC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study
Overview
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.
Detailed description
Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There are no published studies on how to improve prognosis for this population. One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis. However, PD-1 monoclonal antibody in combination with PD-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in VETC-positive patients. Based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.
Interventions
- Drug PD-1 monoclonal antibody and lenvatinib
Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months. - Drug PD-1 monoclonal antibody
Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.
Primary outcome measures
- Disease-free survival [Time frame: From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months]
Secondary outcome measures (1)
- Overall survival [Time frame: From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Pregnant and lactating women.
- 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.).
- 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.
- Active infection.
- Other significant clinical and laboratory abnormalities that affect the safety evaluation.
- Inability to follow the study protocol for treatment or follow up as scheduled.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wu — Wuhan
Identifiers
NCT: NCT06311929 · Precision AT-01