Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhiyong Huang

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

60 Participants
are divided into 1 treatment group

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