Clinical trial NCT06631326: HAIC in Combination with PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)
Official title: Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors As First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma with Portal Vein Tumor Thrombus: a Target Trial Emulation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HCC - Hepatocellular Carcinoma
Hepatic Arterial Infusion Chemotherapy
BCLC Stage C Hepatocellular Carcinoma
Lenvatinib
PD-1 Inhibitors
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with high tumor burden advanced HCC with PVTT who received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.

Brief summary: The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 80 years old;
2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
5. Presence of PVTT;
6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
7. Child-Pugh class A or B7;
8. Tumor burden meets up to 7 out criteria.

Exclusion Criteria:

1. Patients who took anti-tumor treatments before the combination therapy;
2. With other malignant tumors;
3. incomplete data.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression free survival(PFS) (Overall)
timeFrame: Up to approximately 2 years
measure: Progression free survival(PFS) of intra-hepatic lesions
timeFrame: Up to approximately 2 years
measure: Progression free survival(PFS) of extra-hepatic lesions
timeFrame: Up to approximately 2 years
measure: Progression free survival(PFS) of portal vein tumor thrombus (PVTT)
timeFrame: Up to approximately 2 years
measure: Objective response rate(ORR) per RESCIST 1.1
timeFrame: Up to approximately 2 years
measure: ORR per mRECIST
timeFrame: Up to approximately 2 years
measure: ORR of PVTT
timeFrame: Up to approximately 2 years
measure: Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The first hospital of China medical university
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Haibo Shao
role: PRINCIPAL_INVESTIGATOR
References: