Clinical trial NCT05320692: A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Randomized, Open-Label, Multi-center phase III clinical trial。
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PFS assessed by BIRC
timeFrame: approximately 5 years
Secondary outcomes:
measure: OS
timeFrame: approximately 5 years
measure: ORR
timeFrame: approximately 5 years
measure: DCR
timeFrame: approximately 5 years
measure: DoR
timeFrame: approximately 5 years
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
timeFrame: approximately 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: