Hepatocellular Carcinoma
Conditions
Keywords
TACE, tislelizumab
Brief summary
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
Detailed description
This is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(cTACE) as first-line treatment in BCLC stage C HCC patients without extrahepatic spread. The primary endpoint is time to progression (TTP).
Interventions
DRUGTislelizumab in combination with cTACE
On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle)
Sponsors
Zhongda Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 18-70 years old on the day the patients voluntary to participate in the study and signing in ICF. 2. Histological or clinical diagnosis of HCC. 3. BCLC stage C patients ineligible for surgical resection or liver transplantation. 4. No prior systemic therapy for HCC (including immunotherapy). 5. Have at least one uni-dimensional lesion measurable by CT scan or magnetic resonance imaging per mRECIST. 6. Child-Pugh A-B7. 7. ECOG PS 0-1. 8. Adequate hematological function (absolute neutrophil count ≥ 1.5 X 109/L, platelets count≥50 X109/L, and hemoglobin ≥85 g/L); Adequate hepatic function (both AST and ALT ≤ 3 ULN, serum total bilirubin ≤ 34.2 umol/L or 2mg/dl, serum albumin ≥ 29g/L); Adequate renal function (eGFR \> 30 ml/min/1.73 m2) 9. For patients with HBV or HCV infection, HBV DNA less than 500 IU/ml (2500 copies/ml) or HCV RNA detectable. 10. life expectancy of more than 3 months. 11. Patients must be able to understand and willing to sign a written informed consent document. 12. Patients suitable for TACE therapy assessed by investigators.
Exclusion criteria
1. Tumor thrombus involving main trunk of portal vein or inferior vena cava. 2. Prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at BCLC stage 0-B) or radiotherapy on liver cancer. 3. Disease history of grade 2 or more hepatic encephalopathy. 4. Extrahepatic metastasis on baseline imaging. 5. HIV infection or syphilis. 6. Prior therapies with any anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 agents. 7. Tumor diffuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TTP assessed by independent review committee(IRC) | up to 24 months after enrollment or study close | Defined as the time from the date of first cTACE to the date of first documentation of disease progression per mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | An expected average of 8 months | Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST. |
| ORR | An expected average of 8 months | Defined as the proportion of patients with a documented CR or PR, assessed by IRC and investigators, respectively, per mRECIST. |
| DCR | An expected average of 8 months | Defined as the proportion of patients whose best overall response (BOR) is CR, PR, or SD, assessed by IRC and investigators, respectively, per mRECIST. |
| TTP assessed by investigators | An expected average of 8 months | Defined as the time from the treatment initiation to the date of the first objectively documented tumor progression, assessed by investigators per mRECIST. |
| OS | An expected average of 24 months | Defined as the time from the treatment initiation to the date of death due to any cause. |
| Safety | up to 24 months after enrollment or study close | NCI-CTCAE v5.0. |
| DOR | An expected average of 8 months | Defined as the time from the first confirmation of objective remission (CR or PR) to the first recording of disease progression or death, whichever occurs first, assessed by IRC and investigators, respectively, per mRECIST. |
Countries
China
Contacts
Primary ContactHai-Dong Zhu, MD
Backup ContactRui-Jie Du, MD
Outcome results
None listed