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

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

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

HAIC plus PD-1 inhibitors plus lenvatinib
Drug
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.
PD-1 inhibitors plus lenvatinib
Drug
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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Triple adjuvant therapy groupExperimental treatment 1 intervention

Group B: Dual adjuvant therapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

DFS

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

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

Sponsors and contacts

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Chen Xiaoping

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov

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