HAIC, PD-1 Inhibitors, and Lenvatinib for HCC Treatment
HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
Recruiting
Observational Study
BCLC Stage B Hepatocellular CarcinomaBCLC Stage C Hepatocellular CarcinomaHepatic Arterial Infusion ChemotherapyLenvatinibPD-1Systemic Therapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
84 (estimated)
Sponsor
First Hospital of China Medical University · Other
Who this trial is looking for
This trial is looking for patients with intermediate or advanced liver cancer who have not responded to previous standard treatments. Participants will receive a combination of treatments to see how well they work together.
Are You a Good Fit for This Trial?
Must be takingPD-1 inhibitorsLenvatinib
You may be able to join if
I have been diagnosed with liver cancer.
I have stage C liver cancer with a portal vein tumor.
I have previously received standard treatment for liver cancer that did not work.
I have had at least 2 cycles of HAIC.
I have liver lesions that can be measured.
I am in Child-Pugh class A or B.
You may not be able to join if
The time since my last treatment failure is more than 3 months.
I have other types of cancer.
I cannot follow the timing rules for treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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. B…
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.
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