NCT06248528

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,076 (actual)
• Sponsor: Chen Xiaoping · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. We launched the CHALLENGE-01 study in October 2023. The study consists of two phases: the first phase involves retrospective data collection from 2019 to 2023 and prospective follow-up of survival information. Specifically, the liver resection+ PD-1 inhibitor + lenvatinib (LRPL) cohort included 225 cases, the TACE + PD-1 inhibitor + lenvatinib (TPL) cohort included 205 cases, and the surgery-only treatment cohort included 200 cases as an additional control group. Data analysis from the first phase of the study showed that the median follow-up times for the LRPL and TPL cohorts were 31.6 months and 22.5 months, respectively. Based on retrospective cohort data, we calculated the sample size required for the prospective study (446) and formally initiated the second-phase prospective clinical trial in January 2024. The study completed the required enrollment from nine centers in China by December 31, 2024, but has not yet reached the primary endpoint (OS).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Liver resection	Patients in the intervention group received liver resection and postoperative adjuvant therapy
PROCEDURE	Locoregional therapy	Patients in the control group received locoregional therapy and systemic therapy

Timeline

• Start date: 2019-12-01
• Primary completion: 2024-12-31
• Completion: 2027-01-31
• First posted: 2024-02-08
• Last updated: 2025-07-16

Locations

1 site across 1 country: China