HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hepatic artery infusion chemotherapy, Lenvatinib + PD-1 monoclonal antibody.
- Who it may be relevant to
- Registry conditions: BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, Lenvatinib. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure hepatic artery infusion chemotherapy
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX - Drug Lenvatinib + PD-1 monoclonal antibody
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Primary outcome measures
- Overall survival [Time frame: Up to approximately 2 years]
Secondary outcome measures (8)
- Progression free survival(PFS) (Overall) [Time frame: Up to approximately 2 years]
- Progression free survival(PFS) of intra-hepatic lesions [Time frame: Up to approximately 2 years]
- Progression free survival(PFS) of extra-hepatic lesions [Time frame: Up to approximately 2 years]
- Progression free survival(PFS) of portal vein tumor thrombus (PVTT) [Time frame: Up to approximately 2 years]
- Objective response rate(ORR) per RESCIST 1.1 [Time frame: Up to approximately 2 years]
- ORR per mRECIST [Time frame: Up to approximately 2 years]
- ORR of PVTT [Time frame: Up to approximately 2 years]
- Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
- Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
- Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
- Received at least 2 cycles of HAIC；
- Has repeated measurable intrahepatic lesions;
- Child-Pugh class A or B.
Exclusion criteria
- The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
- With other malignant tumors;
- Unable to meet criteria of combination timeframe described above.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The first hospital of China medical university — Shenyang
Identifiers
NCT: NCT06632093 · CHANCE2417