Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.

Hepatocellular Carcinoma Clinical Trial

Official title:

To Compare the Survival Differences in Patients With HCC and Portal Vein Tumor Thrombosis Treated With Liver Resection-based Therapy Versus Locoregional-based Therapy: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248528
• Other study ID #: CHALLENGE-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: WanGuang Zhang
• Phone: +8613886195965
• Email: wgzhang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. More research is needed to explore the differences between these two approaches.

Description:

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. In recent years, breakthroughs have been made in the treatment of advanced HCC, and systemic drug combinations such as PD-1 inhibitors combined with targeted therapies, and local area therapy combined with systemic therapy have shown excellent anti-tumor effects. Postoperative adjuvant therapy is also advancing, and the combination of adjuvant systemic medications for patients after PVTT has also been effective in reducing postoperative recurrence. Which approach is better for PVTT patients needs to be explored in depth.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 18-75 years

• Pathological type is HCC, and with PVTT

• No extrahepatic HCC

• Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 and Child-Pugh grade A for the liver resection group

• ECOG performing status of 0-2 and Child-Pugh grade A-B for the locoregional-based group

• Adequate hematologic and organ function

Exclusion Criteria:

• Any history of other malignant tumors or recurrent HCC

• Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency

• Any persistent serious liver resection or locoregional therapy-related complications

• Esophageal and/or gastric variceal bleeding within 6 months

• Inability or refusal to comply with the treatment and monitoring

• Participation in other clinical trials

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Liver resection
Patients in the intervention group received liver resection and postoperative adjuvant therapy
• Locoregional therapy
Patients in the control group received locoregional therapy and systemic therapy

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival was defined as the period from study inclusion until death from any cause.	From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months.
Secondary	Adverse effects	Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.	12 months