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Trial Title:
Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.
NCT ID:
NCT06248528
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular carcinoma
Adjuvant therapy
Overall survival
Liver resection
Combined therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Liver resection
Description:
Patients in the intervention group received liver resection and postoperative adjuvant
therapy
Arm group label:
Liver resection-based group
Intervention type:
Procedure
Intervention name:
Locoregional therapy
Description:
Patients in the control group received locoregional therapy and systemic therapy
Arm group label:
Locoregional treatment-based group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
WanGuang Zhang
Phone:
+8613886195965
Email:
wgzhang@tjh.tjmu.edu.cn
Start date:
December 1, 2019
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Chen Xiaoping
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248528
