Clinical trial NCT06079242: Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
Official title: Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Neoplasms
Keywords: Metastatic Colorectal Cancer
90Y
Liver Metastases
SIRT
Radioembolization
SIR-Spheres Microspheres
Lead sponsor: GrandPharma (China) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unresectable metastatic liver tumors from primary colorectal cancer

Brief summary: 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.

Detailed description: This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patients enrolled should already complete the infusion of SIR-Spheres® and data are about to be collected both retrospectively and prospectively. 200 patients are anticipated to be enrolled and followed up for up to 24 months.

Eligibility criteria: Inclusion Criteria:

1. Obtained informed consent for patients to be follow-up prospectively
2. Age≥18 years old
3. Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
4. Received SIR-Spheres®

Exclusion Criteria:

1. Special contraindications from package insert, which includes

   1. Markedly abnormal liver function tests, such as total bilirubin \> 2.0 mg/dL or albumin \<3.0 g/dL
   2. Portal vein thrombosis in the main trunk
   3. Disseminated extrahepatic disease
   4. Previous external beam radiation therapy to the liver
2. Women are lactating or pregnant during the study or plan to be pregnant during the study
3. Patients with mental illness or cognitive impairment
4. Per investigator, patients are non-adherent or reluctant to be followed up

Primary outcomes:
measure: Liver-specific overall response rate (ORR) according to RECIST 1.1
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 24 months
measure: 1-yr OS
timeFrame: 12 months
measure: Progression-free survival(PFS) assessed by the investigator
timeFrame: 24 months
measure: Liver-specific PFS assessed by the investigator
timeFrame: 24 months
measure: ORR assessed by the investigator
timeFrame: 24 months
measure: Objective Duration of tumor response (DOR) assessed by the investigator
timeFrame: 24 months
measure: Duration of liver-specific DOR assessed by the investigator
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: