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Active, Not Recruiting

NCT Number: NCT05320692

A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma

A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Voluntarily participate in this study and sign informed consent.
  • Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology / cytology.
  • Baseline imaging examination has at least one measurable lesion.
  • Child-Pugh liver function rating was Grade A Within 7 days before randomization.
  • ECOG PS score within 7 days before randomization: 0 or 1. Other protocol defined inclusion criteria could apply.

Exclusion criteria

  • Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
  • Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
  • Has any active autoimmune disease or a history of autoimmune disease and may relapse.
  • Suffering from hypertension and can not be well controlled by antihypertensive drugs.
  • With clinical symptoms or diseases of the heart that are not well controlled.
  • Previous or current central nervous system metastasis.
  • The subject has congenital or acquired immune deficiency (such as HIV infection).
  • Thrombotic or embolic events occurred within 6 months prior to the start of study treatment.
  • A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding within 6 months prior to the start of study treatment.
  • Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment.
  • Severe, unhealed or cracked wounds and active ulcers or untreated fractures.
  • Known genetic or acquired bleeding or thrombotic tendencies.
  • Severe infection occurred within 4 weeks prior to the start of study treatment.
  • Received live attenuated vaccine treatment within 28 days prior to the start of study treatment.
  • Other investigational drugs were received within 28 days prior to the start of study treatment.
  • According to the assessment of investigator, the subject has other factors that may interfere with the results of the study or cause the forced termination of the study. Other protocol defined exclusion criteria could apply.

Treatment and study plan

TACE+Camrelizumab+Apatinib mesylate

Drug

TACE. Camrelizumab,200mg,iv,once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily,once every 3 weeks.

TACE

Procedure

TACE Alone.

Primary outcomes

  1. PFS assessed by BIRC

    Time frame: approximately 5 years

    PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).

Secondary outcomes

  1. OS

    Time frame: approximately 5 years

    OS is defined as the time from the date of randomization until death due to any cause.

  2. ORR

    Time frame: approximately 5 years

    ORR is defined as the percentage of participants in the analysis population who have a CR or PR.

  3. DCR

    Time frame: approximately 5 years

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.

  4. DoR

    Time frame: approximately 5 years

    DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

  5. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0

    Time frame: approximately 5 years

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Randomized, Open-Label, Multi-center Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) or TACE Alone in Patients With Incurable Hepatocellular Carcinoma

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2022
Registry last updated
Dec 11, 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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