Combining camrelizumab and apatinib with TACE for liver cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Jiangsu Province Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xuehao Wang, professor
• Email: Wangxh@njmu.edu.cn
• Phone: 86-025-68303211

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.