Meng Chao Hepatobiliary Hospital of Fujian Medical University
Phase
Observational
Started
2022-08-20
Last updated
2025-05-13
Condition(s) studied
Hepatocellular Carcinoma
Study summary
To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-free survival(PFS) — Up to 2 years PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.
Trial sites (1)
Facility
City
Region
Status
Mengchao Hepatobiliary Hospital, Fujian Medical University
Fuzhou
Fujian
Recruiting
More Meng Chao Hepatobiliary Hospital of Fujian Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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