BridgeMD
New treatment option for Hepatocellular Carcinoma
Official title A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents
ClinicalTrials.gov ID: NCT05718492
What this study is testing
What is FOLFOX (oxaliplatin , leucovorin , fluorouracil , and fluorouracil )?
FOLFOX (oxaliplatin , leucovorin , fluorouracil , and fluorouracil ) 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
- Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatment after the progression of the disease.In view of the effectiveness of Hepatic arterial infusion (HAIC) in the first-line treatment of HCC in the Chinese population, this study intends to launch a prospective intervention study to explore the efficacy and safety of HAIC treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic agents combination therapy, and to provide high-level evidence for optimizing the second-line treatment of advanced HCC in the future.
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
- Cytohistological confirmation is required for diagnosis of HCC. Patients with advanced (unresectable and/or metastatic, stage C based on...
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
- Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
- Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
You likely can't join if
- Local treatments for HCC have been performed within 4 weeks, including surgical resection (including liver transplantation), local ablation...
- A history of liver decompensation, such as refractory ascites, gastrointestinal bleeding, or hepatic encephalopathy; Uncontrolled complications...
- Known to produce allergic or hypersensitive reactions to any study drug or any excipient thereof.
- Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study...
- Tumors of the central nervous system, including metastatic brain tumors. Pregnant women or breast-feeding patients.
- Complicated with other malignant tumors:
See the full eligibility criteria
- Cytohistological confirmation is required for diagnosis of HCC. Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular...
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
- Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
- Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
- Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
- Hemoglobin \> 100g/L Absolute neutrophil count \>3.0 ×109/L Neutrophil count \> 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin \ 28 g/L Prothrombin time (PT)-international normalized ratio (INR) \< 2.3, or PT...
- Local treatments for HCC have been performed within 4 weeks, including surgical resection (including liver transplantation), local ablation, transcatheter arterial chemoembolization (TACE or TAE), radiotherapy...
- A history of liver decompensation, such as refractory ascites, gastrointestinal bleeding, or hepatic encephalopathy; Uncontrolled complications, including but not limited to: Persistent or activity (except the HBV and...
- Known to produce allergic or hypersensitive reactions to any study drug or any excipient thereof.
- Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry.
- Tumors of the central nervous system, including metastatic brain tumors. Pregnant women or breast-feeding patients.
- Complicated with other malignant tumors:
- Malignant tumors that have been treated for therapeutic purposes, have no known active disease for 5 years prior to the first administration of the study drug, and have a low potential risk of recurrence.
- Fully treated non-melanoma skin cancer or malignant freckle moles with no evidence of disease.
- Fully treated carcinoma in situ without evidence of disease.
- Is currently using, or has used an immunosuppressive drug within 14 days prior to the first dose of the investigational drug. This standard has the following exceptions:
- intranasal, inhaled, topical or topical steroids. (e.g., intraarticular) Systemic corticosteroid therapy not exceeding 10 mg/ day of prednisone or its physiological equivalent as a prophylactic use of steroids for...
- Uncontrolled hypertension: systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications ≤ 28 days before randomization or first dose of drug.
- Pregnant or lactating women, or fertile men or women who do not want to use high-efficiency contraceptives, 6 months after the last dosing of study treatment, from screening to study treatment. Based on the patient's...
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.