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NCT Number: NCT07157969

ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC

This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
  • Age ≥18 years at the time of signing informed consent, regardless of gender.
  • Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
  • BCLC Stage B or C.
  • At least one measurable lesion per RECIST 1.1.
  • ECOG score of 0-1.
  • Child-Pugh liver function class A or B.
  • Life expectancy ≥ 3 months.
  • Adequate hematological and organ function.

Exclusion criteria

  • Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
  • Pregnant or breastfeeding women.
  • Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
  • Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
  • History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
  • Presence of unhealed severe wounds, active ulcers, or untreated fractures.
  • Active autoimmune disease or history of autoimmune disorders.
  • Significant history of gastrointestinal diseases.
  • Significant history of cardiovascular or cerebrovascular diseases.

Treatment and study plan

Lenvatinib

Drug

≥60 kg: 12 mg once daily, or <60 kg: 8 mg once daily

Pembrolizumab

Drug

200 mg intravenously every three weeks

Atezolizumab

Drug

1200 mg intravenously every three weeks

Bevacizumab

Drug

15mg/kg intravenously every three weeks

Camrelizumab

Drug

200 mg intravenously every three weeks

apatinib

Drug

250mg once daily

TACE

Procedure

The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

HAIC

Procedure

The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

DEB-TACE

Procedure

The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.

Tislelizumab

Drug

200 mg intravenously every three weeks

Sintilimab

Drug

200 mg intravenously every three weeks

Primary outcomes

  1. ORR, objective response rate

    Time frame: 12 months after the last subject is enrolled

Secondary outcomes

  1. PFS, progression free survival

    Time frame: 12 months after the last subject is enrolled

  2. OS, overall survival

    Time frame: 12 months after the last subject is enrolled

  3. DCR, disease control rate

    Time frame: 12 months after the last subject is enrolled

  4. DoR, duration of response

    Time frame: 12 months after the last subject is enrolled

  5. Adverse events (AE)

    Time frame: 12 months after the last subject is enrolled

  6. Serious adverse events (SAE)

    Time frame: 12 months after the last subject is enrolled

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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