HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

Launched by SULAI LIU · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be removed through surgery. The trial combines a special method of delivering chemotherapy directly to the liver (called HAIC) with two immunotherapy drugs, Durvalumab and Tremelimumab, along with Lenvatinib, a medication that helps to slow down cancer growth. The aim is to see how effective and safe this combination is compared to other treatments.

To participate in this trial, patients need to be between 18 and 70 years old and have a confirmed diagnosis of HCC that cannot be surgically treated. They should also have at least one measurable tumor and be in good health overall, meaning their major organs are functioning properly. Patients who have previously undergone treatment for their cancer may still be eligible if their cancer has progressed. Participants can expect to receive the new treatment while being closely monitored for any side effects. This trial is currently recruiting participants and aims to provide more options for those with advanced liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 \~ 70 years old (including 70 years old), male and female;
• • 2. Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
• • 3. Patients with unresectable or metastatic hepatocellular carcinoma;
• • 4. No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
• • 5. Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
• • 6. At least one assessable lesion (mRECIST criteria);
• • 7. Expected survival time ≥ 3 months;
• • 8. ECOG 0 \~ 1;
• • 9. Child Pugh ≤ 7;
• • 10. Be able to cooperate to observe adverse events;
• 11. Major organs are functioning normally:
• • Hemoglobin ≥ 90 g / L;
• • ANC ≥ 1.5 × 109/L；
• • Platelet count ≥ 75 × 109/L；
• • Albumin ≥ 28 g / L;
• • Total bilirubin ≤ 2 × ULN;
• • AST, ALT ≤ 5 × ULN；
• • ALP ≤ 5 × ULN；
• • Creatinine ≤ 1.5 × ULN；
• • INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。
• Exclusion Criteria:
• • 1. History of symptomatic congestive heart failure, unstable angina pectoris,
• • 2. Uncontrolled cardia arrhythmia
• • 3. History of hepatic encephalopathy
• • 4. Uncontrolled arterial hypertension
• • 5. Co-infection with HBV and HDV