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Randomized Controlled Trial of 100-300 um vs 300-500 um CalliSpheres Loading Microspheres Preloaded with Irinotecan for Transcatheter Arterial Chemoembolization of Unresectable Colorectal Liver Metastases

A randomized, open-label, controlled Trial of 100-300 um versus 300-500 um CalliSpheres drug-loaded microspheres preloaded with irinotecan by transcatheter arterial chemoembolization for unresectable colorectal liver metastases

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046454
Enrollment
Unknown
Registered
2021-05-16
Start date
2021-05-14
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Rectal cancer with liver metastases

Interventions

Group 1:100-300µm pre-loading irinotecan caliis sub-aperture drug carrying microspheres
Group 2:Preloading of 300-500µm irinotecan caliis sub-aperture drug carrying microspheres

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. The patients were diagnosed by pathology and imaging and met the criteria of unresectable colorectal cancer in China Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 Edition); 3. Dysfunction of centerlessness, brain, kidney and other important organs; 4. A or B Child-Pugh; 5. ECOG score 0-2; 6. The patient is expected to survive for more than 3 months. The subjects voluntarily joined the study and signed the informed consent; 7. With good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Child-Pugh C and above, including jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 2. Severe coagulation dysfunction; 3. Total obstruction of the main portal vein, and less collateral vessels; 4. Cachexia or multiple organ failure; 5. Renal dysfunction (urinary creatinine > 20 mg/L or creatinine clearance < 30 mL/min); 6. Contraindications to interventional therapy; 7. Patients with poor compliance such as floating population; 8. patients who have participated in other clinical trials of investigational drugs or devices within four weeks.

Design outcomes

Primary

MeasureTime frame
objective remission rate, ORR;

Secondary

MeasureTime frame
Progression-free survival, PFS;Overall survival, OS;

Countries

China

Contacts

Public ContactWang Tao

Yantai Yuhuangding Hospital

18253560686@163.com+86 18253560686

Outcome results

None listed

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