A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.
Detailed description
Combination therapy for patients with unresectable liver cancer is the future trend, and with the development of therapeutic drugs for liver cancer, especially molecular targeted drugs and immunotherapy drugs, the effective rate of liver cancer treatment has been significantly improved, and the treatment of unresectable liver cancer has gradually changed. possible. Therefore, for patients with unresectable liver cancer, how to choose a combined treatment plan will be an important means to improve the therapeutic effect of liver cancer, and it is also a hot spot in the field of clinical research on liver cancer in recent years.
Based on the above research background, this study is now designed as a non-intervention, selecting patients with unresectable hepatocellular carcinoma as the research subjects to analyze the efficacy and safety of camrelizumab combined with apatinib mesylate. In order to bring more long-term benefits to patients with unresectable hepatocellular carcinoma.
Primary outcome measures
- Progression-free survival（PFS） [Time frame: Up to 2 years]
Secondary outcome measures (4)
- Objective response rate（ORR） [Time frame: Up to 2 years]
- Disease control rate（DCR） [Time frame: Up to 2 years]
- Overall survival（OS） [Time frame: Up to 8 years]
- Occurence of AE and SAE [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Mengchao Hepatobiliary Hospital, Fujian Medical University — Fuzhou
Identifiers
NCT: NCT05409482 · 22-OBU-FJ-CA-ALL-001