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Observational clinical study of camrelizumab combined with apatinib and TACE in adjuvant treatment of patients with high risk of recurrence after radical hepatocellular carcinoma

Observational clinical study of camrelizumab combined with apatinib and TACE in adjuvant treatment of patients with high risk of recurrence after radical hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049661
Enrollment
Unknown
Registered
2021-08-07
Start date
2021-08-15
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Experimental group:Camrelizumab+apatinib+TACE

Sponsors

First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Understand and voluntarily sign the informed consent; 2. Aged 18-75 years, no gender limit; 3. Patients with primary hepatocellular carcinoma; 4. According to the National Health and Family Planning Commission of the People's Republic of China for the diagnosis and treatment of primary liver cancer (2017 edition) clinical staging of liver cancer, patients with stage Ia-IIIa; 5. Child-Pugh score= 5 cm; (2) Single tumor patients: patients with tumor diameter =400 ng/mL; (3) Multiple tumor patients); 8. ECOG score 0-2 points; 9. Normal function of major organs (white blood cell count >= 3 x 10^9 /L, neutrophil count >= 1.5 x 10^9 /L, hemoglobin >= 85g /L, platelet count >= 80 x 10^9 /L, lymphocyte count between 0.6 x 10^9 /L (inclusive) - 4 x 10^9 /L (inclusive) (If the lymphocyte count is not reported in the blood routine report, the lymphocyte count is calculated by white blood cell count x lymphocyte percentage), blood urea nitrogen (BUN) and serum creatinine =34g/L, total bilirubin <=34.2 µmol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both less than or equal to 2.5 times the upper limit of normal); 11. The coagulation function is basically normal (PT prolongation <=4s); 12. Patients with non-viral primary liver cancer are suitable for inclusion; if it is hepatitis B-related primary liver cancer (HBV-HCC) or hepatitis C-related primary liver cancer (HCV-HCC), patients with active viral infection can be treated with antiviral therapy at the same time; 13. The expected survival period is more than 6 months.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of immunodeficiency or autoimmune diseases (such as rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); 2. Patients with a history of other malignant tumors in the past 5 years; 3. Patients who received chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, and hormone therapy within 1 month before screening; 4. Patients who have received liver tumor microwave ablation, cryotherapy, high-power ultrasound focused ablation and other local ablation treatments; 5. Patients with severe allergic history; 6. Patients with severe mental illness; 7. Pregnant or lactating patients: or patients of childbearing age who have a positive blood pregnancy test, and patients of childbearing age and their spouses are unwilling to take effective contraceptive measures during the clinical study and within 6 months after the end of the study; 8. Patients who participated in other clinical trials within 4 weeks before this clinical trial; 9. AIDS or syphilis carriers; 10. Patients with sepsis and other infections and fever that are not effectively controlled; 11. Patients after organ transplantation; 12. Bone marrow transplant patients; 13. Those who have a history of drug abuse or alcoholism but refuse to quit drinking; 14. Patients who are considered by the investigator to be unsuitable for this clinical trial (such as poor compliance, etc.).

Design outcomes

Primary

MeasureTime frame
Disease-free survival time;

Secondary

MeasureTime frame
12-month disease-free survival rate;Overall survival;Time to relapse;

Countries

China

Contacts

Public ContactSun Yuling

First Affiliated Hospital of Zhengzhou University

13462955920@163.com+86 13837184328

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026