Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

HCC Clinical Trial

Official title:

VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311929
• Other study ID #: Precision AT-01
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: WanGuang Zhang
• Phone: +8613886195965
• Email: wgzhang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Intervention

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

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	DFS defined as time to recurrence or death after surgery.	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	Overall survival	OS defined as time to death from any cause after surgery.	From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months