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New treatment option for Hepatocellular Carcinoma
Official title Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial
ClinicalTrials.gov ID: NCT06031285
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as bevacizumab biosimilar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients.
- Phase 2: a mid-size study of how well it works
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
- Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment...
- Child-Pugh score ≤ 6 points (Child-Pugh A);
- BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤...
- Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
- ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
You likely can't join if
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using systemic therapy or local treatment for HCC before enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Those with a known history of central nervous system metastasis or hepatic encephalopathy;
- Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
- Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those...
See the full eligibility criteria
- Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
- Child-Pugh score ≤ 6 points (Child-Pugh A);
- BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
- Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
- ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
- Expected survival period ≥ 12 weeks;
- The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration):
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using systemic therapy or local treatment for HCC before enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Those with a known history of central nervous system metastasis or hepatic encephalopathy;
- Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
- Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of ascites on imaging but not...
- Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Uncontrolled cardiac clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or...
- Abnormal coagulation function (INR\>2.0, PT\>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow the preventive use of low-dose aspirin and low molecular heparin;
- Significant clinically bleeding symptoms or clear bleeding tendency occurred within 3 months before randomization, such as pertussis/hemoptysis 2.5ml or more, gastrointestinal bleeding, esophageal and gastric varices...
- Arterial/venous thrombosis events that occurred within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein...
- Known genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein...
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.