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Associating liver partition and portal vein ligation for staged hepatectomy(ALPPS) +PD1/PD-L1 Inhibitor+Lenvatinib+HAIC in Patients With Initially Unresectable Hepatocellular Carcinoma: a Multicenter Randomized Controlled Trial

Associating liver partition and portal vein ligation for staged hepatectomy(ALPPS) +PD1/PD-L1 Inhibitor+Lenvatinib+HAIC in Patients With Initially Unresectable Hepatocellular Carcinoma: a Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061735
Enrollment
Unknown
Registered
2022-07-01
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

2:ALPPS

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. unresectable HCC diagnosed by clinical, pathological or cytological methods; 2. Criteria of clinical diagnosis: history of liver disease, AFP >= 400ng/mL, classical characteristics of HCC by ultrasound or imaging examination; 3. Imaging examination indicates that lesion(s) is(are) confined within left/right lobe of liver with no limitation of size(s); 3D reconstruction of CT indicates: insufficient ratio of future liver remnant and standardized liver volume (FLR/SLV), that is 18 years old and = 60ml/min; (2) ALT and AST are lower than 2.5 times upper limit of normal respectively, or they could be recovered to this range after treatment; (3) Left ventricular ejection fraction >= 50%; no pericardial effusion; no clinically abnormalities detected by electrocardiogram (ECG). (4) Little or no pleural/peritoneal effusion; oxyhemoglobin saturation (SpO2) >= 95%; 8. Patients who volunteer to participate in this study and sign the informed consent (ICF).

Exclusion criteria

Exclusion criteria: 1. Unable to diagnose HCC; 2. Patients who can tolerate primary resection of tumor with enough liver function and future liver remnant; 3. Child-Pugh score >= 7; ECOG score>= 2; 4. Other factors of patients who cannot tolerate the surgery, such as those who are defined as the intolerable by anesthesiologists after evaluating the function of heart, lung and kidney; 5. HCC patients who have already received other anti-tumor therapies; 6. Patients who are not willingly to participate in this study or cannot participate in the whole process owing to financial or time problems.

Design outcomes

Primary

MeasureTime frame
Tumor resection rate;objective response rate;

Secondary

MeasureTime frame
3 years' survival;Recurrence-free survival;

Countries

China

Contacts

Public ContactChen Yajin

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

cyj0509@126.com+86 13719006202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026