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A prospective cohort study of the safety and efficacy of CalliSpheres-loaded drug-loaded microspheres loaded with doxorubicin-based chemotherapy (DEB-TACE) and cTACE in the treatment of patients with advanced or advanced liver cancer

A prospective cohort study of the safety and efficacy of CalliSpheres-loaded drug-loaded microspheres loaded with doxorubicin-based chemotherapy (DEB-TACE) and cTACE in the treatment of patients with advanced or advanced liver cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025958
Enrollment
Unknown
Registered
2019-09-15
Start date
2019-09-10
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Primary liver cancer

Interventions

Experimental group :DEB-TACE
control group :CTACE

Sponsors

Shandong Institute of Cancer Prevention and Treatment
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, gender is not limited; 2. Histopathological or clinical diagnosis of primary liver cancer, including hepatocellular carcinoma, cholangiocarcinoma and mixed liver cancer. (Refer to the Specifications for the diagnosis and treatment of primary liver cancer (2011 edition) issued by the Ministry of Health of China); 3. The expected survival period is greater than 3 months; 4. Patients who are unable to cure or require declining treatment for various reasons; 5. Liver function Child-Pugh grade A or B; 6. White blood cell count >= 3.0 x 10^9 / L, hemoglobin >= 8.5g / dl, platelet count >= 50 x10^9 / L; 7. INR <= 2.3 or PT extended <= 3 seconds, serum creatinine < 1.5 times the upper limit of normal; 7. ECOG fitness status score <= 2 points; 8. Patients voluntarily join the study and sign an informed consent form (ICF); 9. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the program requirements.

Exclusion criteria

Exclusion criteria: 1. There are obvious venous/intravenous fistulas; uncorrectable coagulopathy and obvious blood abnormalities, with obvious bleeding tendency; refractory massive ascites; 2. Combine active infections, especially biliary system inflammation; 3. Serious heart, lung, kidney, and brain and other important organ diseases; 4. Those who have suffered or are currently concurrent with other malignancies (except for cured basal or squamous cell skin cancer); 5. Events of arteriovenous thrombosis occurring within 12 months prior to screening, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 6. Uncontrolled infections appear during screening; 7. Pregnant or lactating women; 8. Other patients considered by the treating physician to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactJinlong Song

Shandong Institute of Cancer Prevention and Treatment

jls7286@163.com+86 13969080678

Outcome results

None listed

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