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Efficacy and safety of transarterial chemoembolization with drug-loaded microspheres (DEB-TACE) sequential hepatic arterial infusion chemotherapy (HAIC) in patients with unresectable large liver cancer (> 5cm) : a prospective, phase IIB, one-arm study

Efficacy and safety of transarterial chemoembolization with drug-loaded microspheres (DEB-TACE) sequential hepatic arterial infusion chemotherapy (HAIC) in patients with unresectable large liver cancer (> 5cm) : a prospective, phase IIB, one-arm study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073724
Enrollment
Unknown
Registered
2023-07-19
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC

Interventions

Experimental group:DEB-TACE Sequential HAIC

Sponsors

Xijing Hospital Affiliated to Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent 2. Age =18 years old, male or female 3. HCC confirmed by histopathology, cytology, or imaging 4. The maximum diameter of the tumor was > 5cm 5. As assessed by MDT (team of surgeons) as unresectable, resection boundaries are unclear and liver reserve function < 30% 6. Confirm at least one measurable intrahepatic target lesion according to RECIST v1.1 criteria 7. Liver function Child-Pugh grade A and B (within 8 points) without cirrhosis or cirrhosis 8. The physical status score of the United States Eastern Cancer Consortium (ECOG) was less than 1 point 9. Life expectancy is over 3 months

Exclusion criteria

Exclusion criteria: 1. Cancer thrombus accompanied by main portal vein or involving primary branch of bilateral portal vein and no major outflow tract; 2. Patients with diffuse liver cancer; 3. Hepatic decompensation, including: massive ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy; 4. Organ (heart, kidney) dysfunction, unable to tolerate TACE or HAIC treatment; 5. History of other malignant tumors; 6. Have an active infection (including tuberculosis) that requires systematic treatment, other than HCV or HBV; 7. Subjects who have received allogeneic tissue/solid organ transplants; 8. People with HIV history; 9.30 days of gastrointestinal bleeding, or combined with = grade 3 gastrointestinal or non-gastrointestinal fistula; 10.Is currently participating in or has previously participated in an investigational drug study, or has used an investigational device within 4 weeks prior to initial dosing of the investigational drug; Medical history or evidence of disease that may interfere with the test results, prevent the subject from fully participating in the study, abnormal treatment or laboratory values, or the investigator believes that participation in the study is not in the subject's best interest;

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Overall survival rate;Progression-free survival;Therapeutic effective rate;

Countries

China

Contacts

Public ContactAn rui

Xijing Hospital Affiliated to Air Force Medical University

atczln@163.com+86 182 9201 1352

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026