Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Phase 4RecruitingNCT06311929

Chen Xiaoping300 enrolled

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.

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 One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis.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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

HCC

Interventions

PD-1 monoclonal antibody and lenvatinibDRUG

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.

PD-1 monoclonal antibodyDRUG

Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Disease-free survival

DFS defined as time to recurrence or death after surgery.

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 Outcomes

Overall survival

OS defined as time to death from any cause after surgery.

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

Central Contacts

WanGuang Zhang

CONTACT

+8613886195965 wgzhang@tjh.tjmu.edu.cn

Data from ClinicalTrials.gov

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