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

Last updated: February 15, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Cancer

Liver Disease

Cancer/tumors

Treatment

TACE

TACE+Camrelizumab+Apatinib mesylate

Clinical Study ID

NCT05320692
SHR-1210-Ⅲ-336
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily participate in this study and sign informed consent.

  2. Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology /cytology.

  3. Baseline imaging examination has at least one measurable lesion.

  4. Child-Pugh liver function rating was Grade A Within 7 days before randomization.

  5. ECOG PS score within 7 days before randomization: 0 or 1. Other protocol definedinclusion criteria could apply.

Exclusion

Exclusion Criteria:

  1. Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cellcarcinoma and lamellar cell carcinoma.

  2. Subjects who are ready for or have previously received organ or allogeneic bonemarrow transplantation.

  3. Has any active autoimmune disease or a history of autoimmune disease and mayrelapse.

  4. Suffering from hypertension and can not be well controlled by antihypertensivedrugs.

  5. With clinical symptoms or diseases of the heart that are not well controlled.

  6. Previous or current central nervous system metastasis.

  7. The subject has congenital or acquired immune deficiency (such as HIV infection).

  8. Thrombotic or embolic events occurred within 6 months prior to the start of studytreatment.

  9. A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinalbleeding within 6 months prior to the start of study treatment.

  10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment.

  11. Severe, unhealed or cracked wounds and active ulcers or untreated fractures.

  12. Known genetic or acquired bleeding or thrombotic tendencies.

  13. Severe infection occurred within 4 weeks prior to the start of study treatment.

  14. Received live attenuated vaccine treatment within 28 days prior to the start ofstudy treatment.

  15. Other investigational drugs were received within 28 days prior to the start of studytreatment.

  16. According to the assessment of investigator, the subject has other factors that mayinterfere with the results of the study or cause the forced termination of thestudy. Other protocol defined exclusion criteria could apply.

Study Design

Total Participants: 425
Treatment Group(s): 2
Primary Treatment: TACE
Phase: 3
Study Start date:
August 09, 2022
Estimated Completion Date:
July 30, 2026

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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