Actively Recruiting
Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
Led by Zhiyong Huang · Updated on 2024-06-24
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
Z
Zhiyong Huang
Lead Sponsor
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, due to the fact that most patients are already in the middle and late stages of treatment, only about 20% of patients have the opportunity to undergo surgical resection. Palliative cytoreductive surgery has been used in the treatment of a variety of malignant tumors, but it is not recommended for the treatment of HCC. Under the premise of targeted therapy and immunotherapy, palliative hepatectomy can reduce tumor burden and may further improve the therapeutic effect of HCC. The aim of this study is to explore whether palliative hepatectomy combined with targeted therapy and immunotherapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.
CONDITIONS
Official Title
Palliative Hepatectomy Combined With Targeted Therapy and Immunotherapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years (inclusive)
- No previous systemic antitumor or surgical treatment
- Clinical or pathological diagnosis of hepatocellular carcinoma
- Primary liver lesion mainly isolated tumors with tumor burden over 90%, technically resectable
- Either intrahepatic metastases (≥3 tumors, total diameter ≤3 cm), or limited extrahepatic metastases (max one organ, ≤3 tumors, total diameter ≤3 cm), or portal/hepatic vein tumor thrombus removable with main tumor
- ECOG performance status score of 0-1, without significant organ dysfunction
- Child-Pugh class A liver function
- HBV-DNA less than 1×10^5 copies/ml and receiving antiviral therapy
- Adequate organ function (WBC ≥2.5×10^9/L; Platelet ≥75×10^9/L; Hemoglobin ≥9 g/dL; ALT and AST ≤3×ULN; Total Bilirubin ≤3×ULN; INR ≤1.5×ULN; Prothrombin Time ≤1.5×ULN; Creatinine ≤1.5×ULN)
- Expected survival of more than 3 months
- Postoperative patients with measurable tumors ≥1 cm by RECIST v1.1
- Willing to provide informed consent
You will not qualify if you...
- History or active malignancy except cured over 5 years or completely treated in situ cancers
- Central nervous system metastasis or brain metastasis history
- History of organ transplantation
- Surgery of head, chest, or abdomen within past 6 months
- Child-Pugh class C liver function or massive ascites
- Active infection within 7 days after systemic antibiotics
- Active coronary artery disease, severe or unstable angina, or recent heart attack within 12 months
- Thrombotic or embolic events within past 12 months (stroke, pulmonary embolism, deep vein thrombosis)
- NYHA class II or higher congestive heart failure
- HIV infection, AIDS, positive syphilis, or untreated active hepatitis (high HBV-DNA or HCV-RNA)
- Active or suspected autoimmune disease requiring systemic immunosuppressive therapy
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases
- Pregnant or breastfeeding women or positive pregnancy test
- Investigator judgment of unsuitability due to clinical/laboratory abnormalities or compliance
- Severe psychological or mental disorders
- Participation in another drug clinical trial within past 4 weeks
- Other investigator-determined reasons unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
Z
Zhiyong Huang
CONTACT
E
Erlei Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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