About this trial
Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population.
Eligibility criteria
Qualifiers
Patients aged 18 to 75 years (inclusive).
No prior systemic antitumor treatment or meeting the criteria for splenectomy during treatment.
Clinical or pathological diagnosis of hepatocellular carcinoma (HCC) that is unresectable initially or has recurred after surgery.
HBV-DNA less than 1*10^5 copies/ml and undergoing antiviral therapy.
Disqualifiers
History of or concurrent active malignancy (excluding malignancies that have been cured for over 5 years or in situ cancers that can be completely cured with adequate treatment).
Presence of central nervous system metastasis or a history of brain metastasis.
History of organ transplantation.
History of surgery in the head, chest, or abdomen within the past six months.
Trial design
Treatments tested in this trial
- Splenectomy+Targeted therapy+ Immunotherapy
Treatment groups
Sponsors and collaborators
Zhiyong Huang
Lead sponsor
Tongji Hospital
Sponsor institution
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Zhongnan Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Taihe Hospital
Collaborator
Hubei Cancer Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Wuhan Central Hospital
Collaborator
Yichang Third Renmin Hospital
Collaborator