Combining TACE with Camrelizumab and Rivoceranib for treating advanced liver cancer

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

This study is testing if combining a liver cancer treatment called TACE with two targeted therapies, Camrelizumab and Rivoceranib, can help people with advanced liver cancer feel better and improve their outcomes.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 425 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Camrelizumab, Apatinib
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05320692 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of transarterial chemoembolization (TACE) combined with Camrelizumab and Rivoceranib (Apatinib) in patients diagnosed with incurable hepatocellular carcinoma (HCC). Participants will undergo TACE alongside the administration of these targeted therapies to assess their combined impact on tumor response and patient outcomes. The study aims to determine whether this combination can improve treatment results compared to standard approaches. It is a Phase 3 interventional trial, indicating a focus on confirming effectiveness and safety in a larger patient population.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with hepatocellular carcinoma who have measurable lesions and meet specific liver function and performance status criteria.

Not a fit: Patients with certain types of liver cancer, uncontrolled hypertension, or significant autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with advanced liver cancer.

How similar studies have performed: While this specific combination is novel, previous studies have shown promising results with TACE and targeted therapies in liver cancer treatment.

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.

Where this trial is running

Shanghai, Shanghai

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Linna Wang

Conditions Hepatocellular Carcinoma