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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE; Drug: TACE+Camrelizumab+Apatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05320692

SHR-1210-Ⅲ-336

Details and patient eligibility

About

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.

Enrollment: 423 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 defined inclusion criteria could apply.

Exclusion criteria

1. Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
2. Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
3. Has any active autoimmune disease or a history of autoimmune disease and may relapse.
4. Suffering from hypertension and can not be well controlled by antihypertensive drugs.
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 study treatment.
9. A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding 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 of study treatment.
15. Other investigational drugs were received within 28 days prior to the start of study treatment.
16. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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423 participants in 2 patient groups

Treatment group

Experimental group

Description:

TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).

Treatment:

Drug: TACE+Camrelizumab+Apatinib mesylate

Control group

Active Comparator group

Description:

TACE Alone.

Treatment:

Procedure: TACE