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Trial Title:
Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma
NCT ID:
NCT05957640
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
SIRT
Study type:
Interventional
Study phase:
Phase 1
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:
Yttrium-90 carbon microspheres SIRT
Description:
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres
Arm group label:
Yttrium-90 carbon microspheres
Summary:
To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with
unresectable hepatocellular carcinoma
Detailed description:
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable
hepatocellular carcinoma 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 hepatocellular carcinoma. The primary endpoints are safety
and local objective response rate of liver target lesions. While the secondary endpoints
include the time to progression, progression-free survival rates, disease control rates,
duration of response, quality of life 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 hepatocellular carcinoma based on EASL or AASLD guidelines;
4. Without extrahepatic metastases, inoperable or refuse surgical resection;
5. At least one well defined tumor (mRECIST 1.1);
6. Tumor burden ≤ 50% of the total liver volume;
7. Child-Pugh score ≤ 7;
8. Adequate organ function: # 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; # 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; #
Renal function: Cr ≤ 1.5 ULN; creatinine clearance ≥ 50 mL/min (calculated according
to Cockcroft-Gault formula); # Coagulation function: international normalized ratio,
prothrombin time and activated partial thromboplastin time were less than 1.5 ULN; #
Cardiovascular function: left ventricular ejection fraction ≥ 50%;
9. 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 anticancer treatment is stable (≤ 2 grade)
and hair loss];
10. 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. Participated in other trial within 1 month before yttrium-90 administration;
10. Pregnant and lactating women;
11. Serious infections in active stage or need systematic treatment;
12. With positive results of HIV antibody test;
13. The researchers judge that there is unresolved toxicity from previous treatment and
will continue to exist, which may endanger the safety of patients;
14. The researcher judged clinical or laboratory examination abnormality or other
reasons;
15. Extrahepatic disease or combined with other malignant tumors;
16. Hepatic artery angiography and 99mTc MAA hepatic artery perfusion imaging
demonstrate gastrointestinal shunts, which may not be remedied through vascular
intervention techniques.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gao-Jun Teng
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Gao-Jun Teng, MD
Start date:
May 5, 2023
Completion date:
May 31, 2025
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/NCT05957640
