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OncoMatch/Clinical Trials/NCT06349980

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

Is NCT06349980 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HLX53 (1000mg) and HLX53 (2000mg) for carcinoma, hepatocellular.

Phase 2RecruitingShanghai Henlius BiotechNCT06349980Data as of May 2026

Treatment: HLX53 (1000mg) · HLX53 (2000mg) · HLX10 · HLX04The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Disease stage

Required: Stage BCLC STAGE C, BCLC STAGE B (NOT SUITABLE FOR LOCOREGIONAL THERAPY) (BCLC)

Barcelona Clinic Liver Cancer (BCLC) stage C; BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: T cell co-stimulation or immune checkpoint therapy

Previous treatment with any T cell co-stimulation or immune checkpoint therapy (e.g., CTLA-4, PD-1 inhibitors, PD-L1/2 inhibitors, etc.)

Cannot have received: anti-VEGF therapy (bevacizumab)

previous treatment with bevacizumab or its biosimilars

Cannot have received: anti-TIGIT therapy or related targets (CD155 antibodies, CD112 antibodies, CD113 antibodies)

previous treatment with anti-TIGIT therapy or related targets (such as CD155, CD112, or CD113 antibodies, etc.)

Lab requirements

Blood counts

adequate hematologic and end-organ function

Liver function

child-pugh grade a and good grade b (≤ 7 points)

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

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