Triple vs. Dual Adjuvant Therapy Following Liver Resection for HCC.

ConditionHCC
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaoping

About this trial

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. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored.

Eligibility criteria

Qualifiers

Aged 18-75.

No previous local or systemic treatment for hepatocellular carcinoma.

Child-Pugh liver function score ≤ 7.

ECOG PS 0-1.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HAIC plus PD-1 inhibitors plus lenvatinib
  • PD-1 inhibitors plus lenvatinib

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chen Xiaoping

Lead sponsor

Tongji Hospital

Sponsor institution