Lenvatinib and Sintilimab for Liver Cancer Treatment
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Recruiting
Phase 2
Interventional Study
Hepatocellular Carcinoma Non-resectable
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 320 (estimated)
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University · Other
Who this trial is looking for
This trial is looking for patients with liver cancer that is larger than 7 cm and has spread to the portal vein. Participants will receive a combination of medications and treatments to see how well they work together.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with liver cancer.
- The largest part of my tumor is larger than 7 cm.
- My imaging tests show portal vein tumor thrombosis.
- My cancer has come back after treatment.
- My overall health status is good (Eastern Cooperative Oncology Group performance status ≤1).
- I have Child-Pugh class A or B liver function.
- I have enough healthy blood and organ function.
- My life expectancy is at least 3 months.
You may not be able to join if
- I have a tumor in my vena cava.
- My cancer has spread to my brain.
- I have had previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy.
- I have heart or kidney problems that prevent me from having TACE or HAIC.
- I have a history of other cancers.
- I have an uncontrollable infection.
- I have a history of HIV.
- I have received an organ or cell transplant.
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.
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About This Trial
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* a confirmed diagnosis of HCC
* the largest intrahepatic lesion \>7 cm
* presence of PVTT on imaging
* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/…
Contacts