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Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases (NRT-uCRLM)

Primary Purpose

Unresectable Colorectal Liver Metastases

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Colorectal Liver Metastases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Eastern Cooperative Oncology Group performance status ≤ 1; Expected survival time ≥ 3 months; Confirmed liver metastasis of colorectal cancer; Complete resection and no local recurrence of the primary colorectal cancer; Intolerance, failure to the previous anti-tumor treatments or, or recurrence liver metastasis after surgical resection; Without extrahepatic metastases, inoperable or refuse surgical resection; At least one well defined tumor (RECIST 1.1); Tumor burden ≤ 50% of the total liver volume; Child-Pugh score ≤ 7; Adequate organ function: ① Blood routine [no blood transfusion or colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil count ≥ 1.5 × 109/L; platelet ≥ 75 × 109/L; hemoglobin ≥ 90 g/L; ② Liver function: total bilirubin ≤ 2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase ≤ 5. 0 ULN; alkaline phosphatase ≤ 2.5 ULN; Albumin > 30 g/L; ③ Renal function: Cr ≤ 1.5 ULN; creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); ④ Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN; ⑤ Cardiovascular function: left ventricular ejection fraction ≥ 50%; According to CTCAE 5.0 standard, all adverse events of previous systematic anti-cancer treatment have recovered to baseline or ≤ 1 grade, [except for the following: neuropathy induced by previous anti-cancer treatment is stable (≤ 2 grade) and hair loss]; Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial. Men are forbidden to donate sperm. The pregnancy test results of female patients of childbearing age during the screening period and within 24 hours before administration must be negative. Exclusion Criteria: With previous history of hepatic encephalopathy; Severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity < 50% or forced expiratory volume at one second /predicting value < 50% or maximum volume per minute < 50 L/min);Obvious chronic obstructive pulmonary disease or interstitial pneumonia; Percentage of hepatopulmonary shunt > 10%, or the single lung radiation absorbed dose > 30 Gy; With hepatic artery malformation and unable to intubate hepatic artery; Tumor thrombus in main portal vein; Have received radiotherapy or transcatheter arterial chemoembolization (patients who have received transcatheter arterial non-iodized oil chemoembolization are judged by researchers); The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted therapy) was less than 4 weeks before the drug administration; Clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis; Major surgery or severe trauma within 28 days before yttrium-90 administration; Participated in other trial within 1 month before yttrium-90 administration; Pregnant and lactating women; Serious infections in active stage or need systematic treatment; With positive results of HIV antibody test; The researchers judge that there is unresolved toxicity from previous treatment and will continue to exist, which may endanger the safety of patients; The researcher judged clinical or laboratory examination abnormality or other reasons.

Sites / Locations

  • Zhongda Hospital Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yttrium-90 carbon microspheres

Arm Description

Single dose of yttrium-90 carbon microspheres injection. Patients will be assessed by SPECT-CT imaging within 24 hours for yttrium-90 distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available).

Outcomes

Primary Outcome Measures

Progression Free Survival Rate of Liver Target Lesions
Survival probability of patients without imaging progression of liver target lesions

Secondary Outcome Measures

Adverse events
Rate of adverse events
Yttrium-90 distribution
Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available)
Objective response rate (ORR)
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Duration of response (DOR)
Time without imaging progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Hepatic progression-free survival (hPFS)
Time without imaging progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time to progression (TTP)
Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Progression-free survival (PFS)
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Overall survival (OS)
Survival time
Disease control rate (DCR)
Probability of tumor control

Full Information

First Posted
December 25, 2022
Last Updated
January 26, 2023
Sponsor
Zhongda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05692037
Brief Title
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases
Acronym
NRT-uCRLM
Official Title
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases: A Multicentre, Prospective, Open-label, Single-arm Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases
Detailed Description
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases remain unknown. This multicentre, prospective, open-label, single-arm trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases. The primary endpoints are the progression-free survival rates of liver target lesions. While the secondary endpoints include the safety, tumor control, and the distribution characteristics of yttrium-90 carbon microspheres.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Colorectal Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yttrium-90 carbon microspheres
Arm Type
Experimental
Arm Description
Single dose of yttrium-90 carbon microspheres injection. Patients will be assessed by SPECT-CT imaging within 24 hours for yttrium-90 distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available).
Intervention Type
Combination Product
Intervention Name(s)
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
Intervention Description
Yttrium-90 carbon microspheres SIRT
Primary Outcome Measure Information:
Title
Progression Free Survival Rate of Liver Target Lesions
Description
Survival probability of patients without imaging progression of liver target lesions
Time Frame
3 months after yttrium-90 injection
Secondary Outcome Measure Information:
Title
Adverse events
Description
Rate of adverse events
Time Frame
Up to 24 months
Title
Yttrium-90 distribution
Description
Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.Ten Patients will be tested for the radioactivity of yttrium-90 in blood, urine, and feces (if available)
Time Frame
Within 24 hours
Title
Objective response rate (ORR)
Description
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time Frame
Up to 24 months
Title
Duration of response (DOR)
Description
Time without imaging progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time Frame
Up to 24 months
Title
Hepatic progression-free survival (hPFS)
Description
Time without imaging progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time Frame
Up to 24 months
Title
Time to progression (TTP)
Description
Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time Frame
Up to 24 months
Title
Progression-free survival (PFS)
Description
Evaluated by the investigator and independent image review committee respectively (CTCAE 1.1)
Time Frame
Up to 24 months
Title
Overall survival (OS)
Description
Survival time
Time Frame
Up to 24 months
Title
Disease control rate (DCR)
Description
Probability of tumor control
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group performance status ≤ 1; Expected survival time ≥ 3 months; Confirmed liver metastasis of colorectal cancer; Complete resection and no local recurrence of the primary colorectal cancer; Intolerance, failure to the previous anti-tumor treatments or, or recurrence liver metastasis after surgical resection; Without extrahepatic metastases, inoperable or refuse surgical resection; At least one well defined tumor (RECIST 1.1); Tumor burden ≤ 50% of the total liver volume; Child-Pugh score ≤ 7; Adequate organ function: ① Blood routine [no blood transfusion or colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil count ≥ 1.5 × 109/L; platelet ≥ 75 × 109/L; hemoglobin ≥ 90 g/L; ② Liver function: total bilirubin ≤ 2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase ≤ 5. 0 ULN; alkaline phosphatase ≤ 2.5 ULN; Albumin > 30 g/L; ③ Renal function: Cr ≤ 1.5 ULN; creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); ④ Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN; ⑤ Cardiovascular function: left ventricular ejection fraction ≥ 50%; According to CTCAE 5.0 standard, all adverse events of previous systematic anti-cancer treatment have recovered to baseline or ≤ 1 grade, [except for the following: neuropathy induced by previous anti-cancer treatment is stable (≤ 2 grade) and hair loss]; Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial. Men are forbidden to donate sperm. The pregnancy test results of female patients of childbearing age during the screening period and within 24 hours before administration must be negative. Exclusion Criteria: With previous history of hepatic encephalopathy; Severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity < 50% or forced expiratory volume at one second /predicting value < 50% or maximum volume per minute < 50 L/min);Obvious chronic obstructive pulmonary disease or interstitial pneumonia; Percentage of hepatopulmonary shunt > 10%, or the single lung radiation absorbed dose > 30 Gy; With hepatic artery malformation and unable to intubate hepatic artery; Tumor thrombus in main portal vein; Have received radiotherapy or transcatheter arterial chemoembolization (patients who have received transcatheter arterial non-iodized oil chemoembolization are judged by researchers); The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted therapy) was less than 4 weeks before the drug administration; Clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis; Major surgery or severe trauma within 28 days before yttrium-90 administration; Participated in other trial within 1 month before yttrium-90 administration; Pregnant and lactating women; Serious infections in active stage or need systematic treatment; With positive results of HIV antibody test; The researchers judge that there is unresolved toxicity from previous treatment and will continue to exist, which may endanger the safety of patients; The researcher judged clinical or laboratory examination abnormality or other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hai-Dong Zhu, MD
Phone
+862583262224
Email
zhuhaidong9509@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaojun Teng, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases

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