Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: Liver resectionProcedure: Locoregional therapy
- Registration Number
- NCT06248528
- Lead Sponsor
- Chen Xiaoping
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liver resection-based group Liver resection Patients in the liver resection-based group received adjuvant PD-1 inhibitors plus targeted drugs following liver resection. Locoregional treatment-based group Locoregional therapy Patients in the locoregional treatment-based group received PD-1 inhibitors plus targeted drugs following locoregional therapy.
- Primary Outcome Measures
Name Time Method Overall survival From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months. Overall survival was defined as the period from study inclusion until death from any cause.
- Secondary Outcome Measures
Name Time Method Adverse effects 12 months Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
🇨🇳Wuhan, Hubei, China