BridgeMD
New treatment option for Advanced Hepatocellular Carcinoma
Official title A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06363825
What this study is testing
What is camrelizumab?
camrelizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced hepatocellular carcinoma.
Also referred to as apatinib.
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
- To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load
- 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 80
You may be able to join if
- 1\. The people voluntarily joined the study, had good compliance, cooperated with follow-up, and obtained written informed consent;
- 2\. Age: 18 years old ≤80 years old, both male and female;
- 3\. In accordance with the "Norms for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)" formulated by the National Health...
- 4\. There is at least one measurable lesion (spiral CT scan diameter ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1...
- 5\. Have not received systematic treatment before;
You likely can't join if
- 1\. Pregnant or lactating women;
- 2\. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured skin basal cell carcinoma...
- 3\. Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
- 4\. Patients who have participated in other clinical trials in the past three months;
- 5\. Received local treatment (such as surgical resection, radiation therapy, ablative therapy, treatment therapy, etc.) within the past 1 month;
- 6\. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary...
See the full eligibility criteria
- 1\. The people voluntarily joined the study, had good compliance, cooperated with follow-up, and obtained written informed consent;
- 2\. Age: 18 years old ≤80 years old, both male and female;
- 3\. In accordance with the "Norms for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)" formulated by the National Health Commission and the 2018 EASL liver Cancer guidelines formulated by the European...
- 4\. There is at least one measurable lesion (spiral CT scan diameter ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard, see Annex 5 for RECIST version 1.1);
- 5\. Have not received systematic treatment before;
- 6.CNLC was divided into stages Ⅱa-Ⅲb;
- 7\. Meet the status of high tumor load, and meet one of the following conditions: 1) High tumor load is defined according to the 7-11 criteria: combined with the number of tumors and the maximum tumor size, high tumor...
- 8\. The Child-Pugh classification of liver function is grade A or B (5-8 points);
- 9.ECOG PS score 0-1;
- 10\. Expected survival ≥12 weeks;
- 11\. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA≤2000, treatment can be started directly; If HBV-DNA \> 2000, start antiviral therapy for one week and then start treatment.
- 12\. The major organs function properly and meet the following criteria:
- The standard of blood routine examination must meet: (no blood transfusion within 14 days)
- Hemoglobin (HB) ≥100g/L,
- White blood cell count (WBC)≥3×10\^9/L
- Absolute neutrophil count (ANC)≥1.5×10\^9/L,
- Platelet (PLT)≥50×10\^9/L;
- Biochemical examination shall meet the following standards:
- Bilirubin (BIL)\<1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST\<5ULN;
- Serum creatinine (Cr) ≤1.5ULN
- 13\. Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial period and 8...
- 1\. Pregnant or lactating women;
- 2\. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ);
- 3\. Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
- 4\. Patients who have participated in other clinical trials in the past three months;
- 5\. Received local treatment (such as surgical resection, radiation therapy, ablative therapy, treatment therapy, etc.) within the past 1 month;
- 6\. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, except portal vein thrombosis, occurred within 6 months prior to...
- 7\. Immunosuppressants or systemic hormone therapy (dose \>10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
- 8\. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment;
- 9\. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding; Platelet count \< 50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant...
- 10\. Refractory ascites, bad fluid;
- 11\. Active infection, especially inflammation of the biliary system;
- 12\. Severe liver, kidney, heart, lung, brain and other major organ failure;
- 13\. Previous use of targeted drugs, any component of PD-1 MAB or other similar tests A quick person;
- 14\. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
- 15\. Previous serious cardiovascular disease, including but not limited to the following diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval...
- 16\. Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantity \> 1.0g);
- 17\. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption;
- 18\. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or interfere with the patient's completion of the study.
- 19\. Patients who do not wish to undergo histological examination to confirm the diagnosis.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, 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.