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

NCT07340502 | Not Yet Recruiting

• 1 other identifier: CHALLENGE-06
• Study Type: observational
• Target: 364
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

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

  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 (2)

• Overall survival(OS)

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

• Objective Response Rate (ORR)

  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 (1)

• Prespecified subgroup analyses

  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.

Study Arms (2)

TACE-based combination treatment cohort

Patients in this group were treated with TACE plus a PD-1 inhibitor and lenvatinib

Procedure: TACE; Drug: PD-1inhibitors; Drug: Lenvatinib

HAIC-based combination treatment cohort

Patients in this group were treated with HAIC plus a PD-1 inhibitor and lenvatinib

Procedure: HAIC; Drug: PD-1inhibitors; Drug: Lenvatinib

Interventions

TACE PROCEDURE

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.

TACE-based combination treatment cohort

HAIC PROCEDURE

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.

HAIC-based combination treatment cohort

PD-1inhibitors DRUG

200mg was given intravenously every three weeks.

HAIC-based combination treatment cohort; TACE-based combination treatment cohort

Lenvatinib DRUG

The dose is determined by body weight, body weight greater than or equal to 60kg, 12mg, oral; Less than 60kg, 8mg, orally.

HAIC-based combination treatment cohort; TACE-based combination treatment cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
• Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain).

You may not qualify if:

• 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;
• Human immunodeficiency virus (HIV) infection; or active viral hepatitis (e.g., hepatitis B or C);
• Tumor thrombus involving the inferior vena cava, hepatic veins, or the main portal vein trunk.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

lenvatinib

Study Officials

• Wanguang Zhang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanguang Zhang

CONTACT

13886195965; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01