TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma

ConditionHCC

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorTongji Hospital

About this trial

Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-"HAIC plus PD-1 inhibitor and lenvatinib" versus "TACE plus PD-1 inhibitor and lenvatinib"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 75 years;

Tumor stage classified as BCLC-A to -C, with no evidence of extrahepatic metastasis;

Newly diagnosed, treatment-naïve hepatocellular carcinoma with no prior anticancer therapy;

Child-Pugh liver function score ≤ 7;

Disqualifiers

Decompensated liver cirrhosis;

Concurrent other malignancies or recurrent hepatocellular carcinoma;

Any active, known, or suspected autoimmune disease;

History of hypersensitivity to any component of PD-1 inhibitors or lenvatinib;

Trial population

This is a multicenter, prospective, observational cohort study designed to evaluate the efficacy and safety, primarily in terms of progression-free survival (PFS), of transarterial chemoembolization (TACE) versus hepatic arterial infusion chemotherapy (HAIC), each combined with a PD-1 inhibitor and lenvatinib, in the treatment of unresectable hepatocellular carcinoma (HCC). The study plans to enroll a total of 364 patients, who will be prospectively followed for treatment efficacy and adverse events. The primary endpoint is PFS. Secondary endpoints include the objective response rate (ORR), overall survival (OS), and safety.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

TACE
Procedure/Surgery
TACE blocks the tumor's blood supply while delivering high concentrations of chemotherapy agents directly into the hepatic artery. Patients received on-demand TACE until the end of the study or tumor progression.
HAIC
Procedure/Surgery
HAIC involves the continuous infusion of high-dose chemotherapy into the hepatic artery via an indwelling catheter, enabling prolonged and deep tumor exposure. Patients received on-demand HAIC until the end of the study or tumor progression.
PD-1inhibitors
Drug
200mg was given intravenously every three weeks.
Lenvatinib
Drug
The dose is determined by body weight, body weight greater than or equal to 60kg, 12mg, oral; Less than 60kg, 8mg, orally.

Treatment groups

364 Participants

are divided into 2 treatment groups

Group A: TACE-based combination treatment cohort3 interventions

Group B: HAIC-based combination treatment cohort3 interventions

Trial outcomes

Primary outcomes

Progression-free survival (PFS)

PFS was defined as the time from enrollment to tumor progression.

Time frame

From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.

Secondary outcomes

Overall survival(OS)

OS was defined as the time from enrollment to death.

Time frame

From date of enrollment until the date of death from any cause, assessed up to 96 months.

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the proportion of patients who achieve a best response of either complete response (CR) or partial response (PR) during a specified treatment period.

Time frame

From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.

Other outcomes

Prespecified subgroup analyses

Prespecified subgroup analyses were defined based on: (1) tumor distribution (confined to one hepatic lobe vs. involvement of both lobes); (2) tumor number (single vs. 2-3 vs. ≥3 tumors); and (3) tumor stage (BCLC stage A vs. B vs. C).

Time frame

From the date of enrollment, until the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.

Locations

This trial has no locations.

Sponsors and contacts

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

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov

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