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

NCT06311942 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-05-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

HAIC plus PD-1 inhibitors plus lenvatinib

Patients in the triple adjuvant therapy group received one cycle of HAIC about a month after liver resection, HAIC was adopted the FOFOLX6 program (Folinic acid+5-fluorouracil+Oxaliplatin). The first cycle of PD-1 monoclonal antibody was administrated 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles. Lenvatinib was initiated orally 2-4 weeks postoperatively for 6 months.

DRUG

PD-1 inhibitors plus lenvatinib

The first cycle of PD-1 monoclonal antibody was administrated 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles. Lenvatinib was initiated orally 2-4 weeks postoperatively for 6 months.

Sponsors & Collaborators

  • Chen Xiaoping

    lead OTHER

Principal Investigators

  • xiaoping Chen · Tongji Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311942 on ClinicalTrials.gov