Actively Recruiting
Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2024-09-23
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving blank-microsphere transcatheter arterial embolization and hepatic arterial infusion chemotherapy (bTAE-HAIC) with the drugs oxaliplatin, 5-fluorouracil, and leucovorin, along with Lenvatinib and Camrelizumab for patients who have intermediate to advanced large hepatocellular carcinoma (liver cancer). This prospective, single-arm study aims to assess the safety and effectiveness of this combined approach, as previous studies have shown individual treatments to be effective but not in this combination. The treatment involves a procedure where a microcatheter is inserted into the artery feeding the tumor, and blank microspheres are delivered based on the tumor's blood supply. After this, chemotherapy drugs are infused directly into the hepatic artery every four weeks. Alongside this, patients receive daily oral Lenvatinib and intravenous Camrelizumab every two weeks. The study focuses on this combination therapy without a comparison group. Participants will be monitored over six months to measure the objective response rate to the treatment. Assessments include clinical evaluations and laboratory tests to monitor liver function, blood counts, and other safety markers. Researchers will also track progression-free survival and other outcomes. The study lasts until December 2025, with careful safety monitoring throughout to evaluate the treatment's effects on tumor response and patient health.
CONDITIONS
Brief Title
bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of hepatocellular carcinoma
- Age between 18 and 75 years
- Maximum tumor size of at least 10 cm and total tumor size of 15 cm or more
- Intermediate-advanced huge hepatocellular carcinoma or advanced hepatocellular carcinoma with specified portal vein tumor thrombus types or limited metastases (5 or fewer)
- Child-Pugh class A or B liver function
- Eastern Cooperative Group performance status score of 0 to 2
- Hemoglobin level at least 8.5 g/dL
- Total bilirubin level no more than 30 mmol/L
- Serum albumin level at least 32 g/L
- AST and ALT no more than 5 times the upper normal limit
- Serum creatinine no more than 1.5 times the upper normal limit
- INR no more than 1.5 or normal prothrombin time and partial thromboplastin time
- Absolute neutrophil count above 1500/mm3
- Prothrombin time 18 seconds or less or INR less than 1.7
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Diffuse hepatocellular carcinoma
- More than 5 extrahepatic metastases
- Obstructive portal vein tumor thrombus involving the main portal vein
- Serious medical comorbidities
- Evidence of liver decompensation such as ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Known history of HIV infection
- History of organ transplant
- Known or suspected allergy to study drugs or related agents
- Cardiac ventricular arrhythmias needing anti-arrhythmic treatment
- Evidence of bleeding disorders
- Clinically significant gastrointestinal bleeding within 30 days before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing during the treatment period as determined by the study
Participants receive a combination treatment including a bTAE procedure with hepatic arterial infusion chemotherapy every 4 weeks, daily oral Lenvatinib, and intravenous Camrelizumab every 2 weeks.
bTAE-HAIC every 4 weeks, Camrelizumab every 2 weeks, daily Lenvatinib dosing
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qunfnag Zhou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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