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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04344158 | A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC) | PHASE3 | ACTIVE NOT_RECRUITING | 648 | — | — | Aug 11, 2020 | Dec 1, 2026 | Feb 20, 2025 | 81 | China |
OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
| Arm | Type | Description |
|---|---|---|
| AK105 combined with Anlotinib | EXPERIMENTAL | AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). |
| Sorafenib Tosylate Tablets | ACTIVE_COMPARATOR | Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| AK105 Injection | DRUG | AK105 200mg intravenously (IV) on day 1 of each 21-day cycle. |
| Anlotinib Hydrochloride Capsules | DRUG | Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). |
| Sorafenib Tosylate Tablets | DRUG | Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle. |
Inclusion Criteria: * 1\. 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months. 2\. Histopathology or cytology confirmed as HCC. 3. Has not received any systematic treatment for HCC. 4. Stage B or C in the Barcelona Clinic Live...