NCT05409482Recruiting
A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 25 May 2022
- Start date
- 20 Aug 2022
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Meng Chao Hepatobiliary Hospital of Fujian Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05409482
What you commit to
- Study type: Observational
- Planned participants: 300
- From 20 Aug 2022 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- 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.
Other illness
- 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;
- Severe liver, kidney, heart, lung, brain and other major organ failure;
Other
- Pregnant or breastfeeding women;
- Patients who have participated in other clinical trials in the past three months;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mengchao Hepatobiliary Hospital, Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.