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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320692
• Other study ID #: SHR-1210-?-336
• Status: Recruiting
• Phase: Phase 3
• Start date: August 9, 2022
• Est. completion date: July 30, 2026

Study information

• Verified date: October 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Linna Wang
• Phone: +0518-81220121
• Email: linna.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Procedure:
• TACE
TACE Alone.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OS	OS is defined as the time from the date of randomization until death due to any cause.	approximately 5 years
Secondary	ORR	ORR is defined as the percentage of participants in the analysis population who have a CR or PR.	approximately 5 years
Secondary	DCR	DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.	approximately 5 years
Secondary	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
Secondary	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0		approximately 5 years