NCT06079242Not yet recruiting
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 13 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (mCRC) refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres in China.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 22 Sept 2023
- Start date
- 15 Oct 2023
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- GrandPharma (China) Co., Ltd.
- NCT number
- NCT06079242
What you commit to
- Study type: Observational
- Planned participants: 200
- From 15 Oct 2023 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with mental illness or cognitive impairment
Lab values
- Special contraindications from package insert, which includes
- Markedly abnormal liver function tests, such as total bilirubin \> 2.0 mg/dL or albumin \<3.0 g/dL
- Portal vein thrombosis in the main trunk
- Disseminated extrahepatic disease
- Previous external beam radiation therapy to the liver
Other
- Women are lactating or pregnant during the study or plan to be pregnant during the study
- Per investigator, patients are non-adherent or reluctant to be followed up
Who the study is looking for
- Obtained informed consent for patients to be follow-up prospectively
- Age≥18 years old
- Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
- Received SIR-Spheres®
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.