Clinical trial NCT06632093: HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
Official title: Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BCLC Stage B Hepatocellular Carcinoma
BCLC Stage C Hepatocellular Carcinoma
Hepatic Arterial Infusion Chemotherapy
Lenvatinib
PD-1
Systemic Therapy
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and 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 intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.


Eligibility criteria: Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
6. Received at least 2 cycles of HAIC；
7. Has repeated measurable intrahepatic lesions;
8. Child-Pugh class A or B.

Exclusion Criteria:

1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
2. With other malignant tumors;
3. Unable to meet criteria of combination timeframe described above.

Primary outcomes:
measure: Overall survival
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:
References: