Not Yet RecruitingPhase 1/2

Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer

116 participantsStarted 2025-12-23

Plain-language summary

This trial is an open-label, dose-escalation, and randomized controlled Phase Ib/II clinical study for second-line treatment in participants with advanced hepatocellular carcinoma (HCC). Its primary objective is to evaluate the safety, tolerability, pharmacokinetic profiles, and efficacy of transcatheter arterial infusion of HA131 combined with systemic therapy in the second-line treatment of participants with advanced HCC.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Diagnosis of long QT syndrome, or QTcF (corrected QT interval using Fridericia's formula) ≥ 450 ms in males and ≥ 470 ms in females during screening (only one ECG recheck is permitted during screening, with the result of the last ECG in the screening period taken as final);
✕. High-grade atrioventricular block;
✕. Malignant arrhythmia poorly controlled by medication;
✕. History of chronic heart failure with NYHA (New York Heart Association) functional class ≥ 3;
✕. Severe valvular heart regurgitation or stenosis requiring treatment;
✕. Acute coronary syndrome or severe myocardial disease (including primary cardiomyopathy and other severe myocardial diseases assessed by the investigator) within 6 months prior to screening; severe pericardial disease (including acute pericarditis, constrictive pericarditis and other severe pericardial diseases assessed by the investigator) within 6 months prior to screening;
✕. Left ventricular ejection fraction (LVEF) \< 50% as indicated by echocardiography;

What they're measuring

Phase Ib-DLT

Timeframe: 3years

Phase Ib- AE

Timeframe: 3years

Phase II- ORR

Timeframe: 3years

Trial details

NCT IDNCT07282509

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-26

Contact for this trial

Clinical Trials Information Group officer

86-0311-69085587 ctr-contact@cspc.cn

View on ClinicalTrials.gov More Advanced Hepatocellular Carcinoma (HCC) trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Diagnosis of long QT syndrome, or QTcF (corrected QT interval using Fridericia's formula) ≥ 450 ms in males and ≥ 470 ms in females during screening (only one ECG recheck is permitted during screening, with the result of the last ECG in the screening period taken as final);
✕. High-grade atrioventricular block;
✕. Malignant arrhythmia poorly controlled by medication;
✕. History of chronic heart failure with NYHA (New York Heart Association) functional class ≥ 3;
✕. Severe valvular heart regurgitation or stenosis requiring treatment;
✕. Acute coronary syndrome or severe myocardial disease (including primary cardiomyopathy and other severe myocardial diseases assessed by the investigator) within 6 months prior to screening; severe pericardial disease (including acute pericarditis, constrictive pericarditis and other severe pericardial diseases assessed by the investigator) within 6 months prior to screening;
✕. Left ventricular ejection fraction (LVEF) \< 50% as indicated by echocardiography;