A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma

Recruiting now

Conditions studied: Hepatocellular Carcinoma

In brief

To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.

Key facts

Study ID

NCT05409482

Run by

Meng Chao Hepatobiliary Hospital of Fujian Medical University

People needed

300

Starts

2022-08-20

Expected to finish

2026-03-01

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 years old ≤ age ≤ 75 years old, both male and female;
• Strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition) or hepatocellular carcinoma patients diagnosed by histopathological or cytological examinations , and at least one measurable lesion (according to the mRECIST1.1 standard, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the malignant lymph node is ≥15mm);
• Not previously accepted Patients with hepatocellular carcinoma who have progressed/intolerable and unresectable after systemic therapy or first-line systemic therapy;
• CNLC stage IIb-IIIb;
• Child-Pugh liver function grade A or B (5- 7 points);
• ECOG PS score 0-1 points;
• Expected survival period ≥ 12 weeks;
• If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA ≤ 2000, you can start directly Treatment; if HBV-DNA>2000, antiviral treatment should be given for one week before starting treatment;
• The subjects volunteered to join the study, had good compliance, and cooperated with follow-up.

You may not qualify if…

• Pregnant or breastfeeding women;
• Patients with contraindications to immunotherapy, including but not limited to the following: post-transplantation patients, patients with severe autoimmune diseases, patients with organ failure, patients who have previously experienced adverse reactions of grade 4 or above using immunotherapy, and uncontrolled infectious diseases;
• Use immunosuppressive or systemic hormone therapy within 14 days before enrollment to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent hormones);
• It has been confirmed that camrelizumab Patients who are allergic to injections, apatinib mesylate tablets and their excipients, or are allergic to other monoclonal antibodies;
• Patients with impaired consciousness or inability to cooperate with treatment, combined with mental illness;
• Patients who have participated in other clinical trials in the past three months;
• Severe liver, kidney, heart, lung, brain and other major organ failure;
• According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.

Where it is running

• Mengchao Hepatobiliary Hospital, Fujian Medical University — Fuzhou, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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