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New treatment option for Hepatecellular Carcinoma
Official title QL1706 in Combination With Bevacizumab and RALOX HAIC for Hepatocellular Carcinoma With Vp3/4 PVTT
ClinicalTrials.gov ID: NCT07327788
What this study is testing
What is Iparomlimab and Tuvonralimab Injection (QL1706)?
Iparomlimab and Tuvonralimab Injection (QL1706) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatecellular 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 goal of this prospective, single-arm, multi-center Phase II clinical trial is to evaluate the clinical efficacy and safety of QL1706 combined with bevacizumab and RALOX hepatic artery infusion chemotherapy in treating liver cancer patients with VP3/4 portal vein tumor thrombus. It will also explore molecular biomarkers that predict the efficacy of this combined therapy.
- 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 and older
You may be able to join if
- Voluntarily sign the informed consent form;
- Aged ≥ 18 years, male and female people are both eligible;
- Clinically or pathologically confirmed hepatocellular carcinoma (HCC), with no prior systemic anti-tumor therapy for HCC (including but not limited...
- Complicated with Type VP3 or VP4 portal vein tumor thrombosis (PVTT);
- Confirmed to have at least one measurable target lesion by imaging examination during the screening period in accordance with RECIST v1.1 criteria...
You likely can't join if
- Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocellular carcinoma...
- Active autoimmune disease, or a history of autoimmune disease with potential for recurrence (including but not limited to: autoimmune hepatitis...
- Administration of immunosuppressants or systemic hormonal therapy for immunosuppressive purposes within 2 weeks prior to the first study medication...
- Current interstitial pneumonia or interstitial lung disease, a history of interstitial pneumonia or interstitial lung disease requiring hormonal...
- Confirmed active pulmonary tuberculosis. For people with suspected active pulmonary tuberculosis, a definitive diagnosis shall be made based on chest...
- Known hypersensitivity to the active ingredients or excipients of the study drugs, or a history of severe hypersensitivity to any other monoclonal...
See the full eligibility criteria
- Voluntarily sign the informed consent form;
- Aged ≥ 18 years, male and female people are both eligible;
- Clinically or pathologically confirmed hepatocellular carcinoma (HCC), with no prior systemic anti-tumor therapy for HCC (including but not limited to molecular targeted therapy, systemic chemotherapy, immunotherapy...
- Complicated with Type VP3 or VP4 portal vein tumor thrombosis (PVTT);
- Confirmed to have at least one measurable target lesion by imaging examination during the screening period in accordance with RECIST v1.1 criteria. The measurable lesions should not have received local treatment such as...
- Child-Pugh score ≤ 7 points (Child-Pugh class A-B);
- The maximum diameter of liver tumor ≥ 7 cm;
- ECOG performance status 0 to 1;
- Expected survival time ≥ 12 weeks;
- Function of vital organs meeting the following requirements: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count ≥ 50×10⁹/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 29 g/L; Bilirubin ≤ 2 × upper limit of normal...
- Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocellular carcinoma, mixed hepatocellular carcinoma, etc.;
- Active autoimmune disease, or a history of autoimmune disease with potential for recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis...
- Administration of immunosuppressants or systemic hormonal therapy for immunosuppressive purposes within 2 weeks prior to the first study medication (dose \> 10 mg/day prednisone or an equivalent dose of other hormones);
- Current interstitial pneumonia or interstitial lung disease, a history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis, organizing pneumonia (e.g...
- Confirmed active pulmonary tuberculosis. For people with suspected active pulmonary tuberculosis, a definitive diagnosis shall be made based on chest imaging, sputum examination, and clinical symptoms and signs;
- Known hypersensitivity to the active ingredients or excipients of the study drugs, or a history of severe hypersensitivity to any other monoclonal antibody or anti-angiogenic targeted drugs;
- Known history of central nervous system (CNS) metastasis or hepatic encephalopathy;
- A history of allogeneic stem cell transplantation or solid organ transplantation;
- Moderate to severe ascites with clinical symptoms requiring therapeutic paracentesis or drainage (except for patients with only a small amount of ascites shown by imaging without clinical symptoms), or uncontrolled...
- Severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Severe cardiac rhythm or conduction abnormalities (e.g., ventricular or supraventricular arrhythmias requiring clinical intervention...
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 and older. 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.