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NCT06311929 | RECRUITING | HCC

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma
Sponsor:

Chen Xiaoping

Information provided by (Responsible Party):

Chen Xiaoping

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.

Condition or disease

HCC

Intervention/treatment

PD-1 monoclonal antibody and lenvatinib

PD-1 monoclonal antibody

Phase

PHASE4

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 One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis.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

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study
Actual Study Start Date : 2024-04-01
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Location Details

NCT06311929

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Locations

RECRUITING

China, Hubei

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

Wuhan, Hubei, China, 430000