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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: TACE+Camrelizumab+Apatinib mesylate; Procedure: TACE

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).	Drug: TACE+Camrelizumab+Apatinib mesylate; TACE. Camrelizumab，200mg，iv，once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily，once every 3 weeks.
Active Comparator: Control group; TACE Alone.	Procedure: TACE; TACE Alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS is defined as the time from the date of randomization until death due to any cause.	approximately 5 years
ORR	ORR is defined as the percentage of participants in the analysis population who have a CR or PR.	approximately 5 years
DCR	DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.	approximately 5 years
DoR	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.	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Protein Kinase Inhibitors; Estrogens; Estrogens, Non-Steroidal; Apatinib; Chlorotrianisene
• Other Study ID Numbers: SHR-1210-Ⅲ-336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No