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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07543783 | Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial | PHASE2 | NOT YET_RECRUITING | 38 | — | — | Apr 10, 2026 | Aug 31, 2029 | Apr 28, 2026 | - | — |
Percentage of participants achieving complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST v1.1 criteria, assessed by the investigator.
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first, as assessed by the investigator.
| Arm | Type | Description |
|---|---|---|
| TACE-HAIC + Adebrelimab + Low-dose Bevacizumab | EXPERIMENTAL | Participants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours), administered via hepatic artery catheter. Subsequently, participants receive intravenous adebrelimab (1200 mg fixed dose, Q3W) and low-dose bevacizumab (7.5 mg/kg, Q3W). Each treatment cycle is 21 days. Treatment continues until disease progression (RECIST v1.1), unacceptable toxicity, patient withdrawal, conversion to resectable disease, or investigator decision. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd. |
| Name | Type | Description |
|---|---|---|
| Transarterial Chemoembolization (TACE) | PROCEDURE | Transarterial chemoembolization performed as first-line intervention for unresectable hepatocellular carcinoma. |
| Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX) | DRUG | Hepatic arterial infusion chemotherapy with FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours). |
| Adebrelimab | DRUG | Intravenous adebrelimab 1200 mg fixed dose, administered every 3 weeks (Q3W). |
| Low-dose Bevacizumab | DRUG | Intravenous bevacizumab 7.5 mg/kg, administered every 3 weeks (Q3W). |
Inclusion Criteria: Willing to participate and provide written informed consent. Age ≥ 18 years (on the day of signing informed consent). Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinical diagnosis of HCC according to AASLD criteria in patients with cirrhosis. E...