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Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

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. How to improve the prognosis of this group of patients is an urgent issue to be addressed.

Eligibility criteria

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PD-1 monoclonal antibody and lenvatinib

    Drug

    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

    Drug

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Combined adjuvant therapy groupExperimental treatment 1 intervention
Group B: Monotherapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chen Xiaoping

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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