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

NCT ID: NCT05320692

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Randomized, Open-Label, Multi-center phase III clinical trial。
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).

Group Type EXPERIMENTAL

TACE+Camrelizumab+Apatinib mesylate

Intervention Type DRUG

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

Control group

TACE Alone.

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

TACE Alone.

Interventions

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TACE+Camrelizumab+Apatinib mesylate

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

Intervention Type DRUG

TACE

TACE Alone.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHR-1210-Ⅲ-336

Identifier Type: -

Identifier Source: org_study_id

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