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OncoMatch/Clinical Trials/NCT06090656

Bevacizumab in Combination With Sintilimab Versus Transcatheter Arterial Chemoembolization for the Treatment of Intermediate Stage Hepatocellular Carcinoma (Beyond Up-To-Seven Criteria)

Is NCT06090656 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Bevacizumab combined with Sintilimab for hepatocellular carcinoma.

Phase 2RecruitingSun Yat-sen UniversityNCT06090656Data as of May 2026

Treatment: Bevacizumab combined with SintilimabTranscatheter arterial chemoembolization (TACE) is recommended as the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC) (i.e., BCLC stage B). However, these patients is heterogeneous in terms of liver functional, tumor size and tumor number, and not all patients with mid-stage HCC will benefit from TACE. The ORIENT-32 trial confirmed the efficacy of sintilimab in combination with bevacizumab for unresectable hepatocellular carcinoma. No study has yet explored whether this regimen is appropriate for patients with BCLC stage B. The purpose of this study is to explore whether bevacizumab in combination with sintilimab is superior to conventional TACE therapy in patients with HCC with beyond-Up-to-seven criteria.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–0(Fully active)

Prior therapy

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

Cannot have received: systemic antitumor therapy

No systemic systemic antitumor therapy against hepatocellular carcinoma and transhepatic arterial intervention prior to treatment.

Cannot have received: transhepatic arterial intervention

No systemic systemic antitumor therapy against hepatocellular carcinoma and transhepatic arterial intervention prior to treatment.

Lab requirements

Blood counts

platelets >75×10E9/L; leukocytes >3.0×10E9/L; neutrophils >1.5×10E9/L

Kidney function

Serum creatinine less than 1.5 times the upper limit of normal (ULN)

Liver function

Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 3 times the ULN, Child-Pugh A, no ascites, normal coagulation function, albumin ≥ 30g/L

Child-Push A Normal hematologic function (platelets >75×10E9/L; leukocytes >3.0×10E9/L; neutrophils >1.5×10E9/L) Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 3 times the ULN No ascites, normal coagulation function, albumin ≥ 30g/L Serum creatinine less than 1.5 times the upper limit of normal (ULN)

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

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