Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma: A Multicentre, Prospective, Open-label, Single-arm Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957640
• Other study ID #: CHANCE2303-NRT6003-HCC
• Status: Recruiting
• Phase: Phase 1
• Start date: May 5, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2023
• Source: Zhongda Hospital
• Contact: Lei Zhang, MD
• Phone: +862583262224
• Email: zhang_lei[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable hepatocellular carcinoma

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Combination Product:
• Yttrium-90 carbon microspheres SIRT
Selective internal radiation therapy (SIRT) with yttrium-90 carbon microspheres

Locations

Country	Name	City	State
China	Gao-Jun Teng	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Rates of adverse events	Up to 24 months
Primary	Objective response rates (ORR)	Liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)	3 months after yttrium-90 injection
Secondary	Hepatic time to progression (hTTP)	Time to progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)	Up to 24 months
Secondary	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.	Within 24 hours
Secondary	Progression Free Survival Rate (PFS)	Survival probability of patients without imaging progression of liver target lesions	3 months after yttrium-90 injection
Secondary	Time to progression (TTP)	Time with tumor progression, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)	Up to 24 months
Secondary	Disease control rate (DCR)	Probability of tumor control	Up to 24 months
Secondary	Duration of response (DOR)	Time without imaging progression, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)	Up to 24 months
Secondary	Alpha fetoprotein (AFP)	The variation of AFP levels	Up to 24 months
Secondary	Quality of life (QoL)	The variation of QoL with EORCT QLQ-C30	Up to 24 months
Secondary	Resection rate of liver target lesions	Resection rate of liver target lesions	Within 6 months