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Trial Title:
Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases
NCT ID:
NCT05692037
Condition:
Unresectable Colorectal Liver Metastases
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
Description:
Yttrium-90 carbon microspheres SIRT
Arm group label:
Yttrium-90 carbon microspheres
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group performance status ≤ 1;
2. Expected survival time ≥ 3 months;
3. Confirmed liver metastasis of colorectal cancer;
4. Complete resection and no local recurrence of the primary colorectal cancer;
5. Intolerance, failure to the previous anti-tumor treatments or, or recurrence liver
metastasis after surgical resection;
6. Without extrahepatic metastases, inoperable or refuse surgical resection;
7. At least one well defined tumor (RECIST 1.1);
8. Tumor burden ≤ 50% of the total liver volume;
9. Child-Pugh score ≤ 7;
10. 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%;
11. 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];
12. 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:
1. With previous history of hepatic encephalopathy;
2. 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;
3. Percentage of hepatopulmonary shunt > 10%, or the single lung radiation absorbed
dose > 30 Gy;
4. With hepatic artery malformation and unable to intubate hepatic artery;
5. Tumor thrombus in main portal vein;
6. Have received radiotherapy or transcatheter arterial chemoembolization (patients who
have received transcatheter arterial non-iodized oil chemoembolization are judged by
researchers);
7. The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted
therapy) was less than 4 weeks before the drug administration;
8. Clinical manifestations of portal hypertension, moderate-severe or refractory
ascites, or decompensated liver cirrhosis;
9. Major surgery or severe trauma within 28 days before yttrium-90 administration;
10. Participated in other trial within 1 month before yttrium-90 administration;
11. Pregnant and lactating women;
12. Serious infections in active stage or need systematic treatment;
13. With positive results of HIV antibody test;
14. The researchers judge that there is unresolved toxicity from previous treatment and
will continue to exist, which may endanger the safety of patients;
15. The researcher judged clinical or laboratory examination abnormality or other
reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongda Hospital Southeast University
Address:
City:
Nanjing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Gaojun Teng, MD
Start date:
December 28, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Zhongda Hospital
Agency class:
Other
Source:
Zhongda Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05692037