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

NCT05320692 | Active Not Recruiting Phase 3

• 1 other identifier: SHR-1210-Ⅲ-336
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS assessed by BIRC

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

  approximately 5 years

Secondary Outcomes (5)

• OS

  approximately 5 years

• ORR

  approximately 5 years

• DCR

  approximately 5 years

• DoR

  approximately 5 years

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

  approximately 5 years

Study Arms (2)

Treatment group

EXPERIMENTAL

TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).

Drug: TACE+Camrelizumab+Apatinib mesylate

Control group

ACTIVE COMPARATOR

TACE Alone.

Procedure: TACE

Interventions

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.

Treatment group

TACE PROCEDURE

TACE Alone.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Randomized, Open-Label, Multi-center phase III clinical trial。

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: August 9, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

CN (1)