Combining camrelizumab and apatinib with TACE for liver cancer treatment

Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial

This study is testing if combining two medications with a liver cancer treatment before surgery can help people with liver cancer live longer and have fewer problems after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: camrelizumab, apatinib, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05613478 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of camrelizumab combined with apatinib mesylate in the perioperative treatment of resectable hepatocellular carcinoma (HCC). Participants will be randomized into two groups: one receiving neoadjuvant therapy with TACE, camrelizumab, and apatinib before surgery, and the other receiving only surgery followed by adjuvant therapy. The primary goal is to assess the two-year event-free survival rate, while secondary objectives include evaluating surgical resection rates and overall survival. The study aims to improve patient outcomes by reducing recurrence rates associated with HCC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed hepatocellular carcinoma at specific stages (CNLC Ib-IIIa) and a Child-Pugh score of A.

Not a fit: Patients with other active malignancies, certain types of liver cancer, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and reduce recurrence in patients with hepatocellular carcinoma.

How similar studies have performed: Other studies have shown promise in using immunotherapy and targeted therapy for liver cancer, suggesting potential success for this combined approach.

Eligibility criteria

Inclusion Criteria:

* Volunteer to participate in this study and sign an informed consent form.
* Age ≥18 years old, no gender limit.
* Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
* CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation.
* Child-Pugh score: A grade (≤6 points).
* ECOG PS score: 0-1 points.

Exclusion Criteria:

* Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.
* Currently accompanied by interstitial pneumonia or interstitial lung disease.
* Existence of active autoimmune disease or history of autoimmune disease and may relapse.
* Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count \>15\*10\^9/L.
* Patients with congenital or acquired immune deficiencies (such as HIV-infected persons).
* Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xuehao Wang, professor

Conditions Hepatocellular Carcinoma; Immunotherapy; Preoperative