Skip to content

Efficacy and safety of neoadjuvant TACE-HAIC regimen in stage Ib narrow-margin hepatocellular carcinoma: A prospective multicenter randomized controlled trial

Efficacy and safety of neoadjuvant TACE-HAIC regimen in stage Ib narrow-margin hepatocellular carcinoma: A prospective multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108723
Enrollment
Unknown
Registered
2025-09-04
Start date
2025-09-05
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Hepatocellular carcinoma

Interventions

Neoadjuvant hepatic arterial chemoembolization combined with hepatic arterial perfusion chemotherapy in the surgical group:Hepatic arterial chemoembolization combined with hepatic arterial perfusion c
Surgery alone group:Direct surgical treatment

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The research subjects understand the content and significance of the study and obtain written informed consent. 2. Gender is not limited, age >=18 years old, <=75 years old; 3. Eastern Cooperative Oncology Group (ECOG) score of 0–1; 4. Liver function Child-Pugh grade A/B; 5. Clinical diagnosis of HCC or pathological diagnosis of HCC by percutaneous liver biopsy; 6. Single hepatocellular carcinoma that meets the stage Ib of liver cancer in China; 7. Based on imaging evaluation and surgical planning, the lesion is adjacent to major vasculature structures (portal vein, hepatic vein, and inferior vena cava), resulting in narrow-margin hepatectomy (resection margin < 1cm); 8. Refer to the "Expert Consensus on the Evaluation of Liver Reserve Function Before Hepatectomy" (2011 edition) to ensure that there is sufficient functional liver volume left after surgery.

Exclusion criteria

Exclusion criteria: 1. No previous anti-tumor therapy; 2. Pathological types other than HCC; 3. The distance of the tumor from the large blood vessel cannot be determined; 4. Complications of severe cirrhosis; 5. History of other malignant tumors.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival of 1 year after surgery;Postoperative pathological evaluation of MVI;Radical surgery completion rate;

Secondary

MeasureTime frame
Overall survival;Objective remission rate;Pathological remission;

Countries

China

Contacts

Public ContactYang Shizhong

Beijing Tsinghua Changgung Hospital

ysza02008@btch.edu.cn+86 173 4653 9401

Outcome results

None listed

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