Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of Sintilimab plus Transcatheter arterial chemoembolization (TACE) in participants with Intermediate-stage unresectable hepatocellular carcinoma with Beyond Up-to-seven Criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE+Sintilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab (200mg ivdrip D1 Q3W) |
| |
| TACE |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival time (mPFS) (mRECIST) | The progression-free survival time (mPFS) is defined as the date from the first TACE to the date of first documented disease progression as assessed by mRECIST or death. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) after enrollment is defined as the first TACE to death from any cause. | Up to approximately 24 months |
| Percentage of Participants With Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39824532 | Derived | Li L, Xu X, Wang W, Huang P, Yu L, Ren Z, Fan J, Zhou J, Zhang L, Wang Z. Safety and efficacy of PD-1 inhibitor (sintilimab) combined with transarterial chemoembolization as the initial treatment in patients with intermediate-stage hepatocellular carcinoma beyond up-to-seven criteria. J Immunother Cancer. 2025 Jan 16;13(1):e010035. doi: 10.1136/jitc-2024-010035. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
TACE will be performed by clinical demand, the interval between two TACEs is not less than 4 weeks. |
|
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
| Up to approximately 24 months |
| Objective response rate (ORR) by RECIST 1.1 and mRECIST | Objective Response Rate according to mRECIST and RECIST 1.1 for HCC | Up to approximately 24 months |
| Progression-free survival time (mPFS) (RECICL) | The progression-free survival time (mPFS) is defined as the first time TACE to the date of first documented disease progression as assessed by RECICL or death, whichever comes earlier. | Up to approximately 24 months |
| Time to Progression (TTP) | Time to Progression (TTP) is defined as the time from first TACE to the date of the first documented tumor progression according to the definition above. | Up to approximately 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |