Clinical trial NCT06248528: Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Adjuvant therapy
Overall survival
Liver resection
Combined therapy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months.
Secondary outcomes:
measure: Adverse effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
state: Hubei
Study officials:
affiliation: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan
name: WanGuang Zhang
role: STUDY_DIRECTOR
References: