Hepatocellular Carcinoma Non-Resectable
Conditions
Keywords
Hepatocellular Carcinoma, yttrium-90, selective internal radiation therapy
Brief summary
This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).
Interventions
PROCEDURESIRT
The patients will receive 1-2 sessions of SIRT.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed or clinically diagnosed HCC * Unresectable HCC as assessed by a team of surgeons * The largest tumor size \> 7 cm * Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * At least one measurable intrahepatic target lesion * Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA) * Child-Pugh score ≤ 7 * ECOG PS ≤ 1 * Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds * life expectancy of at least 6 months
Exclusion criteria
* Macrovascular invasion or extrahepatic metastasis * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy * Organ (heart and kidneys) dysfunction * History of other malignancies * Uncontrollable infection * History of organ or cells transplantation * History of HIV * Pregnant or lactating patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) per mRECIST | 3 years | The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | 3 years | The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1 |
| Progression free survival (PFS) | 3 years | The time from date of treatment initiation until the first occurrence of disease progression (according to mRECIST and RECIST 1.1) or death due to any cause, whichever occurs first. |
| time to response (TTR) | 3 years | The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1) |
| Objective response rate (ORR) per RECIST 1.1 | 3 years | The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1 |
| Overall survival (OS) | 4 years | The time from date of treatment initiation to death due to any cause |
| Adverse Events (AEs) | 3 years | Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0 |
| Duration of response (DOR) | 3 years | Time from first tumor response to first disease progression (mRECIST and RECIST 1.1 assessment) or death from any cause (whichever occurs first) |
Countries
China
Contacts
Primary ContactMingyue Cai, Dr.
Backup ContactKangshun Zhu, Dr.
Outcome results
None listed