Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06904183 | Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT | PHASE2 | RECRUITING | 320 | — | — | Apr 1, 2025 | Mar 31, 2030 | Apr 29, 2025 | 1 | China |
The time from date of randomization until the first occurrence of disease progression (according to mRECIST).
| Arm | Type | Description |
|---|---|---|
| LEN+SIN+DEB-TACE+HAIC | EXPERIMENTAL | Patients will receive the combination treatment of LEN+SIN+DEB-TACE+HAIC. |
| LEN+SIN+DEB-TACE | ACTIVE_COMPARATOR | Patients will receive the combination treatment of LEN+SIN+DEB-TACE. |
| Name | Type | Description |
|---|---|---|
| LEN+SIN+DEB-TACE+HAIC | COMBINATION_PRODUCT | For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE+HAIC. |
| LEN+SIN+DEB-TACE | COMBINATION_PRODUCT | For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE. |
Inclusion Criteria: * a confirmed diagnosis of HCC * the largest intrahepatic lesion \>7 cm * presence of PVTT on imaging * tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * Eastern Cooperative Oncology Group performance status ≤1 * Child-Pugh class A/...