Actively Recruiting
Downstaging Protocol Containing Immunotherapy for HCC Beyond the Milan Criteria Before Liver Transplantation
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-11-29
59
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular Carcinoma (HCC) is the most common liver malignancy and the third leading cause of cancer death worldwide. Due to the shortage of donor organs and the risk of tumor recurrence after transplantation, the restrictive Milan criteria is the standard guideline for liver transplantation (LT) in patients with HCC and liver cirrhosis. The XXL study (Mazzaferro et al, 2020) is the first prospective trial validating that effective and sustained downstage therapy could expand the selection criteria and improve the prognosis of recipients with HCC beyond Milan criteria. However, the optimal DT protocol is poorly defined, especially in the Asian population. Recently, immunotherapies such as immune-checkpoint inhibitors (ICIs) are revolutionizing the management of advanced HCC, the combination of the ICI and other treatment regimens (Anti-VEGF, locoregional therapies et al) produced superior results in patients with advanced-stage HCC compared to those with traditional therapeutic regimens. Therefore, we hypothesize an intensive downstage regimen containing immunotherapy could expand the selection criteria for HCC LT
CONDITIONS
Official Title
Downstaging Protocol Containing Immunotherapy for HCC Beyond the Milan Criteria Before Liver Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent and be willing to follow study visits and tests
- Diagnosed with hepatocellular carcinoma (HCC) per AASLD guidelines
- HCC must be beyond Milan criteria without extrahepatic or lymph node metastases
- For untreated patients: Barcelona clinic liver cancer stage IIb-IIIa with or without portal vein tumor thrombus (PVTT 1-3)
- For late recurrent HCC: recurrence at least 2 years after primary curative treatment, localized in liver, beyond Milan criteria
- For early recurrent HCC: recurrence within 2 years after curative treatment, primary tumor within Milan criteria but combined tumor burden beyond Milan criteria
- Child-Pugh score 7 or less without encephalopathy; controlled ascites allowed
- ECOG performance status 0 to 2; Karnofsky score 60 or higher
- No immunotherapy received within 6 months before enrollment
- Adequate bone marrow, liver, and kidney function
- Estimated survival over 12 weeks before liver transplantation
- No other lethal cancers outside the liver in past 5 years
- Well-controlled hypertension (below 140/90 mmHg) if history present
- Use effective birth control during and 6 months after study
- Voluntary participation with good compliance and follow-up
You will not qualify if you...
- Cholangiocellular carcinoma, mixed liver cancer, or rare liver cancer types
- Recurrent liver cancer with incomplete initial treatment
- Uncontrollable infections, alcoholism, drug abuse, severe heart, lung, brain diseases, psychiatric disorders, HIV, active tuberculosis
- Severe portal hypertension with high bleeding risk
- Bleeding events related to portal hypertension in past 6 months
- Life-threatening events in past 6 months (e.g., heart attack, stroke, major bleeding)
- Severe splenomegaly causing low neutrophils or platelets
- History of grade III hepatic encephalopathy or symptoms needing long-term fluid drainage
- Uncontrolled hypertension or hypertensive crises
- Severe pulmonary hypertension not controlled by medication
- Severe coagulopathy or on continuous blood thinning therapy
- Autoimmune diseases like rheumatoid arthritis, lupus, psoriasis, Crohn's disease, ulcerative colitis
- Major surgery within 4 weeks before first dose or severe allergy to study drugs
- Pregnant or breastfeeding women
- Severe psychiatric or psychological disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 376032
Actively Recruiting
Research Team
L
Li PANG, PhD
CONTACT
L
Leibo Xu, PhD
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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