Trial Title:
Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma
NCT ID:
NCT06310590
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Selective internal radiation therapy
Yttrium-90
Transarterial Radioembolization;
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:
Drug
Intervention name:
NRT6003 Injection
Description:
Selective internal radiation therapy (SIRT) with Yttrium-90 carbon microspheres
Arm group label:
NRT6003 Injection
Other name:
Yttrium-90 carbon microspheres
Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003
Injection in patients with unresectable HCC.
Detailed description:
The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable
HCC remain unknown. This trial is a prospective, multicenter, open-label, single-arm
phase I trial designed to evaluate the safety and efficacy of NRT6003 injection.
The primary objective is to evaluate the safety of NRT6003 Injection. While the secondary
objectives include the assessments of the antitumoral efficacy, the improvement of
patients´ quality of life, and the distribution characteristics of Yttrium-90 in body.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18 to 80 and signed informed consent;
2. Diagnosed as hepatocellular carcinoma clinically, by imaging and/or pathology based
on National Health Commission guideline (2022);
3. Evaluated by the investigator as not suitable for surgical resection/ablation, or
there are other reasons unsuitable for surgical resection/ablation, or the
participant refuses surgical resection/ablation;
4. At least one well defined tumor (mRECIST), assessed by enhanced MRI or CT images;
5. Child-Pugh score ≤ 7;
6. Eastern Cooperative Oncology Group performance status ≤ 1;
7. Tumor burden ≤ 50 percent of the total liver volume;
8. Adequate organ function: (1) Blood routine [no blood transfusion or granulocyte
colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil
count (ANC) ≥ 1.5 × 10^9/L; platelet (PLT) ≥ 80 × 10^9/L; hemoglobin (HGB) ≥ 90 g/
L; (2) Liver function: total bilirubin (TBIL) ≤ 2 times upper limit of normal (ULN);
alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5. 0×ULN; Albumin
> 30 g/L; (3) Renal function: Creatinine (Cr) ≤ 1.5×ULN; creatinine clearance rate
(CCr)≥ 50 mL/min (calculated according to Cockcroft-Gault formula); (4) Coagulation
function: international normalized ratio (INR), prothrombin time (PT) and activated
partial thromboplastin time (APTT) ≤1.5×ULN [If any participant takes warfarin or
heparin for anticoagulation therapy, the investigator should evaluate whether the
participant meet the requirements of the protocol]; (5) Cardiovascular function:
left ventricular ejection fraction (LVEF) ≥ 50 percent assessed by ultrasonic
cardiogram;
9. Women and men of childbearing age must agree to take strict and effective
contraceptive measures during the study period and within 6 months after the end of
the trial. Men are forbidden to donate sperm. The pregnancy test results of female
participants of childbearing age during the screening period and within 24 hours
before administration must be negative.
Exclusion Criteria:
1. With the extrahepatic metastasis or concurrent malignant tumors other than liver
cancer;
2. With the hepatic tumor thrombus (excluding the thrombus limited to liver segments or
lobes);
3. With hepatic artery malformation and unable to intubate hepatic artery;
4. Allergy to contrast agents or anesthetics;
5. Severe pulmonary dysfunction (forced expiratory volume in one second, FEV1/FVC < 50
percent or forced expiratory volume in one second (FEV1) < 50 percent of predicted
value, or maximum voluntary ventilation (MVV) < 50 L/min);
6. With the clinical manifestations of decompensated liver cirrhosis (moderate or
severe ascites, upper gastrointestinal bleeding, hepatic encephalopathy, etc.);
7. With diseases have not been controlled despite aggressive treatment, and which may
affect the safety or the efficacy of the investigational drug in the judgement of
investigators;
8. Active or severely infected participants requiring systemic therapy;
9. With positive results of HIV antibody test;
10. Estimated survival period < 3 months;
11. Have received radiotherapy or transcatheter arterial chemoembolization (participants
who have received transcatheter arterial non-iodized oil chemoembolization are
judged by investigators);
12. Technetium (99mTc)-macroaggregated albumin (MAA) hepatic arterial perfusion imaging
estimates that the NRT6003 injection cannot cover all lesions within the liver
(excluding lesions previously treated by the investigator as non-active or
non-progressive);
13. Hepatic artery angiography and 99mTc-MAA hepatic artery perfusion imaging
demonstrate gastrointestinal shunts, which may not be remedied through vascular
intervention techniques;
14. 99mTc-MAA arterial perfusion imaging shows that the single lung radiation absorbed
dose > 30 Gy;
15. Received antitumor therapy or participated in other interventional clinical trials
within 30 days prior to dosing;
16. Pregnant or lactating women;
17. Have persistent, unrelieved toxicity reaction of CTCAE≥2 grade caused by previous
antitumor treatment (excluding alopecia) judged by investigators;
18. Any other reason that the investigator deems the participant unsuitable for
participating in this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Lianxin Liu
Investigator:
Last name:
Lianxin Liu
Email:
Principal Investigator
Facility:
Name:
Fujian Provincial Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hailan Lin
Investigator:
Last name:
Hailan Lin
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinxiong Huang
Investigator:
Last name:
Jinxiong Huang
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Xu
Investigator:
Last name:
Hao Xu
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hailiang Li
Contact backup:
Last name:
Hui Yang
Investigator:
Last name:
Hailiang Li
Email:
Principal Investigator
Investigator:
Last name:
Hui Yang
Email:
Principal Investigator
Facility:
Name:
Hunan Provincial People's Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Xiang
Investigator:
Last name:
Hua Xiang
Email:
Principal Investigator
Facility:
Name:
Zhongda Hospital, Southeast University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Gaojun Teng, MD
Phone:
+8602583272084
Email:
zdyyjgb@163.com
Investigator:
Last name:
Gaojun Teng, MD
Email:
Principal Investigator
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Haibo Shao
Investigator:
Last name:
Haibo Shao
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Wu
Investigator:
Last name:
Hong Wu
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Southwest Medical University
Address:
City:
Luzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yue Chen
Investigator:
Last name:
Yue Chen
Email:
Principal Investigator
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoliang Shao
Investigator:
Last name:
Guoliang Shao
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Tingbo Liang
Investigator:
Last name:
Tingbo Liang
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Chang Yu
Investigator:
Last name:
Chang Yu
Email:
Principal Investigator
Facility:
Name:
The Southwest Hospital of Army Medical University
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Leida Zhang
Investigator:
Last name:
Leida Zhang
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Wentao Li
Investigator:
Last name:
Wentao Li
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Changjing Zuo
Investigator:
Last name:
Changjing Zuo
Email:
Principal Investigator
Facility:
Name:
The Third Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Liu
Investigator:
Last name:
Hui Liu
Email:
Principal Investigator
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiping Yan
Contact backup:
Last name:
Hongcheng Shi
Investigator:
Last name:
Zhiping Yan
Email:
Principal Investigator
Investigator:
Last name:
Hongcheng Shi
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University Cancer Insititute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Lu
Investigator:
Last name:
Wei Lu
Email:
Principal Investigator
Start date:
August 8, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Chengdu New Radiomedicine Technology Co. LTD.
Agency class:
Industry
Source:
Chengdu New Radiomedicine Technology Co. LTD.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06310590