NCT05409482 A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma
| NCT ID | NCT05409482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meng Chao Hepatobiliary Hospital of Fujian Medical University |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-08-20 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-08-20 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.
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.
Contact & Investigator
Wu h Guo
STUDY DIRECTOR
Mengchao Hepatobiliary Hospital, Fujian Medical University
Frequently Asked Questions
Who can join the NCT05409482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05409482 currently recruiting?
Yes, NCT05409482 is actively recruiting participants. Contact the research team at lamp197311@126.com for enrollment information.
Where is the NCT05409482 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT05409482 clinical trial?
NCT05409482 is sponsored by Meng Chao Hepatobiliary Hospital of Fujian Medical University. The principal investigator is Wu h Guo at Mengchao Hepatobiliary Hospital, Fujian Medical University. The trial plans to enroll 300 participants.
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