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Efficacy and safety of 70-150µm CalliSpheres drug-loaded microspheres and 100-300µm CalliSpheres drug-loaded microspheres in the treatment of patients with primary liver cancer

Efficacy and safety of 70-150µm CalliSpheres drug-loaded microspheres and 100-300µm CalliSpheres drug-loaded microspheres in the treatment of patients with primary liver cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068492
Enrollment
Unknown
Registered
2023-02-21
Start date
2021-12-31
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

liver cancer

Interventions

Experimental group:70-150µm CalliSpheres loaded Orbicin, combined with 100-300µm CalliSpheres loaded Rhetitrexel

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Primary liver cancer confirmed by imaging and/or pathology; 2. The BCLC stage is B, and the sum of the diameters of the lesions is =3cm and =10cm 3. Liver function rating: grades A and B (Child-Pugh score=7); 4. ECOG physical fitness score 0-1 points; 5. No vascular invasion and extrahepatic metastasis; 6. The expected survival of the patient is at least 12 weeks; 7. Sign the informed consent form. 8. Laboratory indicators should meet the following standards: (1) White blood cell count=3.0×109/L (2) Hemoglobin=8.5g/dl (3) Platelet count =50×109/L (4) Both alanine aminotransferase and aspartate aminotransferase are less than 3 times the upper limit of normal (5) Albumin=3.0g/dl (6) Total bilirubin less than 3 times the upper limit of normal (7) International normalized ratio (INR) of prothrombin time <= 2.3 or prothrombin time (PT) not exceeding the upper limit of normal control by 3 seconds. (8) Serum creatinine less than 1.5 times the upper limit of normal

Exclusion criteria

Exclusion criteria: 1. Combined with malignant tumors in other parts; 2. Patients who have received interventional therapy in the past 3. Unstable systemic disease or uncontrolled infection; 4. Patients who are pregnant or breastfeeding; 5. Diagnosis of the hepatic artery revealed an obvious arteriovenous fistula 6. Chronic renal failure; 7. Any unstable condition or condition that may jeopardize the safety of the patient and his/her compliance with the study; 8. Clinically significant gastrointestinal bleeding within 30 days before enrollment; 9. Criteria for discontinuation of treatment (dropout criteria): 10. According to the opinion of the investigator, the patient needs to terminate the treatment if any adverse event occurs; 11. The patient or legal representative requests to stop treatment; 12. The ECOG score of the patient's status rose to 4; 13. Patients lost to follow-up; 14. Withdrawal of informed consent;

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;

Countries

China

Contacts

Public Contactshaohaibo
hainoshao@aliyun.com13840150051

Outcome results

None listed

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