OncoMatch/Clinical Trials/NCT06405061
Evaluation of Effectiveness and Safety of HAIC in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
Is NCT06405061 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab for adebrelimab.
Treatment: Adebrelimab — Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. According to GLOBOCAN 2018 data, liver cancer is the sixth most prevalent tumor in the world, with about 841,100 new liver cancer cases and 781,600 deaths per year globally, which is the second leading cause of tumor deaths in men worldwide. China is a high incidence area of liver cancer, accounting for about 50% of the global incidence and deaths. The treatment of HCC varies according to disease stage, which is based on the BCLC classification system, Child-Pugh liver function rating, and extent of disease. Approximately 30% of HCC cases are diagnosed in the early stages (i.e., BCLC stage 0 or A), and the main treatment options include surgical resection, ablation techniques, and liver transplantation. However, the 5-year recurrence rate remains as high as 70%. The recommended treatment for intermediate stage HCC (i.e., BCLC stage B) is hepatic artery intervention, i.e., transarterial chemoembolization (TACE), but the scope of applicability is limited due to concomitant disease and liver impairment factors, some patients do not derive a survival benefit from it, and patients ultimately progress after treatment and are no longer suitable for further TACE. In recent years, the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted, and studies have reported the feasibility of target drugs combined with ICI, TACE or HAIC for the treatment of unresectable hepatocellular carcinoma. The therapeutic aim of Adebrelimab (SHR-1316) is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells, so that T cells can re-recognize tumor cells and produce killing effects on them. This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy (FOLFIRI) in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage CNLC-IIB, CNLC-IIIA (LIMITED TO COMBINED PORTAL VEIN BRANCH THROMBOSIS CHING'S STAGING GRADE I/II) (CNLC (Chinese guidelines, 2022))
Excluded: Stage PORTAL VEIN BRANCH THROMBOSIS OF GRADE III OR ABOVE IN CHENG'S STAGING
CNLC-IIb to IIIa HCC (IIIa is limited to combined portal vein branch thrombosis Ching's staging grade I/II)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: local therapy
not have received any prior local ... therapy for HCC
Cannot have received: systemic therapy
not have received any prior ... systemic therapy for HCC
Cannot have received: anti-PD-1 antibody
previous treatment with other anti-PD-1 antibodies or other immunotherapy targeting PD-1/PD-L1
Cannot have received: other immunotherapy targeting PD-1/PD-L1
previous treatment with other anti-PD-1 antibodies or other immunotherapy targeting PD-1/PD-L1
Cannot have received: other experimental drug therapy
have received other experimental drug therapy within 28 days prior to initiation of study treatment
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 75 x 10^9/L; hemoglobin ≥ 90 g/L
Kidney function
serum creatinine ≤1.5ULN or Cr clearance >50mL/min
Liver function
Child-Pugh score ≤7; serum albumin ≥29g/L; serum total bilirubin ≤1.5×ULN; ALT, AST, AKP ≤5×ULN
Cardiac function
QTc≤450ms (men); QTc≤470ms (women); LVEF ≥50%; no NYHA class II or higher cardiac insufficiency; no unstable angina; no recent MI; no significant arrhythmia
Vital organs function in accordance with the following requirements (within 7 days prior to initiation of study treatment)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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