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OncoMatch/Clinical Trials/NCT06860490

HAIC Combined with Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

Is NCT06860490 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Bevacizumab Biosimilar for hepatocellular carcinoma (hcc).

Phase 2RecruitingFudan UniversityNCT06860490Data as of May 2026

Treatment: Sintilimab · Bevacizumab BiosimilarTo evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-cancer therapy

No prior systemic therapy for HCC

Cannot have received: endocrine therapy

Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy

Cannot have received: immunotherapy

Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy

Cannot have received: HAIC

Prior treatment with HAIC

Cannot have received: radiation therapy

Exception: Radiotherapy administered less than 4 weeks prior to study treatment start

Radiotherapy administered less than 4 weeks prior to study treatment start

Cannot have received: anti-PD-1 therapy

Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Cannot have received: anti-PD-L1 therapy

Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Cannot have received: anti-PD-L2 therapy

Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Cannot have received: anti-CD137 therapy

Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Cannot have received: anti-CTLA-4 therapy (ipilimumab)

Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Lab requirements

Blood counts

absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L

Kidney function

Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula)

Liver function

Total bilirubin ≤ 3x upper normal limit; SGOT/SGPT ≤ 5 x upper normal limit (ULN); Albumin ≥ 31 g/dL; INR ≤1.25; Child-Pugh scores 5-7

Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; SGOT/SGPT ≤ 5 x upper normal limit (ULN); INR ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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