HAIC Combined With Targeted Therapy and Immunotherapy as Down-stage Therapy of LT

• Status: Not yet recruiting
• Trial end date: 2028-07-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective single center, open-label, non-randomized, single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of HAIC combined with targeted therapy and immunotherapy as down-stage therapy for hepatocellular carcinoma before liver transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Immune Checkpoint Inhibitors; Lenvatinib

Criteria

Inclusion Criteria:

• 1. Written informed consent must be obtained prior to any screening procedures, and the patient is willing and able to comply with scheduled visits, treatment plan and laboratory tests.

2. The diagnosis of HCC is confirmed by at least two types of imaging examination (ultrasound, CT, MRI) with contrast enhanced.

3. The patient with HCC beyond Milan criteria is scheduled for liver transplantation, and has no extrahepatic metastases, lymph node metastases and main portal vein or hepatic vein invasion.

4. The Child-Pugh score of the patient is ≤7, and the patient has no encephalopathy, or controllable ascites.

5. Eastern Cooperative Oncology Group (ECOG) scale for assessment of patient Performance Status (PS score) is≤ 2, and KPS score is ≥60.

6. The patient has not received any systemic treatment within 6 months after the diagnosis of HCC.

7. Adequate bone marrow, liver and renal function are assessed by central lab by means of the following laboratory requirements: (1)Neutrophils≥1.5*109/L; platelets≥50*109/L; (2)Bilirubin ≤2 times the upper limit of normal; Albumin > 28 g/L; Alanine transaminase (ALT) and aminotransferase (AST) ≤ 5 times the upper limit of normal; (4)Prothrombin time (PT)-international normalized ratio (INR) < 1.5, or PT ≥18 seconds; (5)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min(calculated by Cockcroft-Gault formula).

8. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 6 months after the completion of trial.

Exclusion Criteria:

• 1. The patient has suffered from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma.

2. The patient has organic disease of heart, lung and brain, uncontrollable mental illness, serious mental illness, alcoholism or drug abuse, uncontrollable systemic infection, including HIV infection、active tuberculosis and etc.

3. The patient with severe portal hypertension is at higher risk of bleeding as assessed by the investigators.

4. The patient has any life-threatening event in the past 6 months, including but not limited to acute myocardial infarction, unstable angina pectoris, congestive heart failure, cerebrovascular accident, pulmonary embolism, massive haemorrhage, etc.

5. The patient has uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.

6. The patient has severe pulmonary hypertension that cannot be controlled by drugs.

7. The patient has severe coagulation dysfunction, have bleeding tendency or is receiving thrombolysis, or anticoagulation therapy, or antiplatelet therapy.

8. The patient has history of autoimmune diseases such as rheumatism, lupus, psoriasis, crohn's disease and ulcerative colitis.

9.The patient has received any prior systemic chemotherapy or molecular-targeted therapy or immunotherapy for HCC such as Sorafenib, Lenvatinib, PD-1/PD-L1 inhibitor, CAR-T, TCR-T, etc.

10. The Patient has underwent major surgical procedure, or significant traumatic injury within 4 weeks of the start of protocol treatment.

11. The patient is known to have a history of severe allergies to any monoclonal antibodies, targeted therapy drugs, or chemotherapeutic agents.

12. Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial, such as serious laboratory abnormalities, or other family or social factors.