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New treatment option for Liver Transplantation
Official title Downstaging Protocol Containing Immunotherapy for HCC Beyond the Milan Criteria Before Liver Transplantation
ClinicalTrials.gov ID: NCT05475613
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written informed consent must be obtained prior to any screening procedures. Willing and able to comply with scheduled visits, treatment plan and...
- Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma based on the AASLD practice guidelines
- Patients with HCC must be beyond Milan criteria without extrahepatic metastases or lymph node metastases: 3.1 Patients without previous treatment...
- Child-Pugh score≤7, with no encephalopathy. Ascites that diuretics can control are permitted in this study.
- Eastern Cooperative Oncology Group (ECOG) Scale for Assessment of Patient Performance Status (PS score) ≤ 2; KPS score ≥60.
You likely can't join if
- Participants who meet any of the following criteria are not eligible for this study:
- Histologically/cytologically confirmed cholangiocellular carcinoma, mixed-type liver cancer, or other rare types of liver cancer;
- Recurrent liver cancer with inadequate initial treatment (i.e., no complete remission or R0 resection);
- Presence of uncontrollable systemic infections, alcoholism or drug abuse, organic diseases of the heart, lungs, or brain, uncontrolled psychiatric...
- Presence of severe portal hypertension with a high bleeding risk as assessed by the investigator;
- History of bleeding events due to portal hypertension in the past 6 months;
See the full eligibility criteria
Who can join
- Written informed consent must be obtained prior to any screening procedures. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
- Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma based on the AASLD practice guidelines
- Patients with HCC must be beyond Milan criteria without extrahepatic metastases or lymph node metastases: 3.1 Patients without previous treatment: Barcelona clinic liver cancer B-C (China liver cancer stage IIb-IIIa)...
- Child-Pugh score≤7, with no encephalopathy. Ascites that diuretics can control are permitted in this study.
- Eastern Cooperative Oncology Group (ECOG) Scale for Assessment of Patient Performance Status (PS score) ≤ 2; KPS score ≥60.
- Have not received any immunotherapies 6 months before enrollment.
- Adequate bone marrow, liver, and renal function.
- The estimated survival before liver transplantation must be more than 12 weeks (Based on the Model for end-stage liver disease, MELD).
- No other lethal malignancy outside the liver in the past 5 years, such as leukemia, lung cancer, melanoma, etc.
- Patients with a history of hypertension should be well-controlled (\< 140/90 mmHg) on a regimen of anti-hypertensive therapy.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the trial and 6 months after the completion of the trial.
- Patients voluntarily joined the study and signed informed consent with good compliance and follow-up.
What rules you out
- Participants who meet any of the following criteria are not eligible for this study:
- Histologically/cytologically confirmed cholangiocellular carcinoma, mixed-type liver cancer, or other rare types of liver cancer;
- Recurrent liver cancer with inadequate initial treatment (i.e., no complete remission or R0 resection);
- Presence of uncontrollable systemic infections, alcoholism or drug abuse, organic diseases of the heart, lungs, or brain, uncontrolled psychiatric disorders, severe mental illnesses, HIV infection, active tuberculosis...
- Presence of severe portal hypertension with a high bleeding risk as assessed by the investigator;
- History of bleeding events due to portal hypertension in the past 6 months;
- History of any life-threatening event in the past 6 months, including but not limited to acute myocardial infarction, unstable angina, congestive heart failure, cerebrovascular accidents, pulmonary embolism, major...
- Severe splenomegaly or splenomegaly-induced neutropenia (ANC \< 1.5 × 10⁹/L) or thrombocytopenia (platelet count \< 50 × 10⁹/L);
- History of grade III hepatic encephalopathy or clinical symptoms requiring long-term drainage of pleural effusion, ascites, pericardial effusion, etc.;
- Uncontrolled hypertension, history of hypertensive crisis or hypertensive encephalopathy;
- Severe pulmonary hypertension that cannot be controlled by medication;
- Severe coagulopathy, or those receiving thrombolytic treatment or requiring continuous anticoagulant or antiplatelet therapy for any reason;
- History of autoimmune diseases such as rheumatoid arthritis, lupus, psoriasis, Crohn's disease, ulcerative colitis, etc.;
- Major surgical procedure within 4 weeks before the first dose; History of severe allergy to any of the study drugs;
- Female patients who are pregnant or breastfeeding;
- Presence of severe psychiatric or psychological disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.