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NCT Number: NCT06079242

Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310002, China

Location contact

hongming Pan, PhD

CONTACT

[email protected]

0571-86006922

hongming Pan, PhD

PRINCIPAL_INVESTIGATOR

weidong Han, PhD

CONTACT

[email protected]

0571-86006922

weidong Han, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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®

Exclusion criteria

  • 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
  • Women are lactating or pregnant during the study or plan to be pregnant during the study
  • Patients with mental illness or cognitive impairment
  • Per investigator, patients are non-adherent or reluctant to be followed up

Treatment and study plan

Resin microspheres containing yttrium-90 (Y-90)

Device

SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only

Other names: SIR-Spheres® Y-90

Primary outcomes

  1. Liver-specific overall response rate (ORR) according to RECIST 1.1

    Time frame: 24 months

    Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 24 months

    From the day of treatment with yttrium [90Y] resin microspheres to the time of death due to any cause

  2. 1-yr OS

    Time frame: 12 months

    The percentage of subjects treated with yttrium [90Y] resin microspheres who survived at 1 year.

  3. Progression-free survival(PFS) assessed by the investigator

    Time frame: 24 months

    Defined as the time from the date of treatment with the yttrium [90Y] resin microspheres to the time when disease progression or subject death from any cause during the study period was first determined by the investigator according to RECIST 1.1 criteria, whichever occurred first.

  4. Liver-specific PFS assessed by the investigator

    Time frame: 24 months

    Defined as the time from the date of treatment with yttrium [90Y] resin microspheres until the first time progression of liver disease or death of the subject from any cause during the study period was determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurred first.

  5. ORR assessed by the investigator

    Time frame: 24 months

    Defined as the percentage of subjects with complete or partial tumor response as determined by the investigator according to RECIST 1.1 criteria

  6. Objective Duration of tumor response (DOR) assessed by the investigator

    Time frame: 24 months

    Defined as the time from the first documented objective response to tumor recurrence or death from any cause during the study period as determined by the investigator according to RECIST 1.1 criteria, whichever occurs first

  7. Duration of liver-specific DOR assessed by the investigator

    Time frame: 24 months

    Defined as the time from the first documented liver objective remission to liver recurrence or death from any cause during the study period as determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurs first

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Wen, B.S.

CONTACT

[email protected]

027-84399665

xixi Hu, MS

CONTACT

[email protected]

027-84399665

Sponsors and collaborators

Lead sponsor

GrandPharma (China) Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 12, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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