Evaluating camrelizumab and apatinib mesylate for liver cancer treatment

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

This study is testing whether a combination of two drugs, camrelizumab and apatinib mesylate, can help people with liver cancer that can't be surgically removed feel better and improve their health.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Meng Chao Hepatobiliary Hospital of Fujian Medical University (other)
• Drugs / interventions: camrelizumab, apatinib, immunotherapy, prednisone
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05409482 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the efficacy and safety of a combination therapy using camrelizumab and apatinib mesylate in patients with unresectable hepatocellular carcinoma. It focuses on patients who meet specific clinical criteria and have measurable lesions, analyzing how this combination treatment can improve outcomes. The study is designed to provide insights into the potential benefits of this therapeutic approach in a real-world setting, contributing to the evolving treatment landscape for liver cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with unresectable hepatocellular carcinoma who have not responded to previous systemic therapies.

Not a fit: Patients with hepatocellular carcinoma who are not within the specified age range or have Child-Pugh liver function grade C may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with unresectable hepatocellular carcinoma.

How similar studies have performed: Other studies have shown promise with combination therapies in liver cancer treatment, indicating that this approach is both relevant and potentially beneficial.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 years old ≤ age ≤ 75 years old, both male and female;
2. 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);
3. Not previously accepted Patients with hepatocellular carcinoma who have progressed/intolerable and unresectable after systemic therapy or first-line systemic therapy;
4. CNLC stage IIb-IIIb;
5. Child-Pugh liver function grade A or B (5- 7 points);
6. ECOG PS score 0-1 points;
7. Expected survival period ≥ 12 weeks;
8. 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;
9. The subjects volunteered to join the study, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. Pregnant or breastfeeding women;
2. 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;
3. 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);
4. 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;
5. Patients with impaired consciousness or inability to cooperate with treatment, combined with mental illness;
6. Patients who have participated in other clinical trials in the past three months;
7. Severe liver, kidney, heart, lung, brain and other major organ failure;
8. 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 this trial is running

Fuzhou, Fujian

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

Study contacts

• Principal investigator: Yong yi Zeng — Mengchao Hepatobiliary Hospital, Fujian Medical University
• Study coordinator: Yong yi Zeng

Conditions: Hepatocellular Carcinoma