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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

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