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New treatment option for Hepatocellular Carcinoma
Official title TIPS Plus Cadonilimab in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study
ClinicalTrials.gov ID: NCT05882370
What this study is testing
What is Cadonilimab?
Cadonilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
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
- The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.
- 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
- The patient voluntarily joined the study and signed an informed consent form;
- ≥18 and ≤ 75 years old, both male and female;
- Clinically diagnosed or pathologically confirmed hepatocellular carcinoma, at least one measurable focus without local treatment (according to...
- Child-Pugh score ≤ 13 points;
- BCLC-C stage accompanied by tumor thrombosis-associated portal hypertension;
You likely can't join if
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or...
- The number of system treatment lines ≥ 2 lines;
- Severe allergic reaction to other monoclonal antibodies;
- Those with a known history of central nervous system metastasis or hepatic encephalopathy;
- Patients who have received liver transplantation in the past;
See the full eligibility criteria
- The patient voluntarily joined the study and signed an informed consent form;
- ≥18 and ≤ 75 years old, both male and female;
- Clinically diagnosed or pathologically confirmed hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements, the measurable focus spiral CT scan length ≥ 10 mm or...
- Child-Pugh score ≤ 13 points;
- BCLC-C stage accompanied by tumor thrombosis-associated portal hypertension;
- Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
- ECOG score: 0～1;
- 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 absolute count of neutrophils≥1.5×109/L; Platelet ≥50×109/L; Hemoglobin ≥60 g/L; Serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal, the levels of FT3 and FT4 should be examined at the same...
- Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as an intrauterine device, contraceptive, or condom) during the study treatment period and...
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before...
- The number of system treatment lines ≥ 2 lines;
- Severe allergic reaction to other monoclonal antibodies;
- Those with a known history of central nervous system metastasis or hepatic encephalopathy;
- Patients who have received liver transplantation in the past;
- Tumor thrombus beyond the portal vein range, such as hepatic vein, inferior vena cava, right atrium, splenic vein, superior mesenteric vein cancer thrombus, etc.;
- 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;
- Child-Pugh score \>13 points;
- 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...
- Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication; molecular...
- The patient has active infection, fever of unknown origin within 7 days before medication ≥38.5℃, or baseline white blood cell count \>15×109/L; Patients with congenital or acquired immune deficiencies (such as...
- Moderate to severe pulmonary hypertension, pulmonary artery pressure was assessed by ultrasound \>40mmHg；
- The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
- Central nervous system metastasis；
- The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or has previously received apatinib therapy;
- Live vaccine may be vaccinated less than 4 weeks before study medication or may be administered during the study period;
- According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.