BridgeMD
New treatment option for Hepatocellular Carcinoma
Official title BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases
ClinicalTrials.gov ID: NCT07062055
What this study is testing
What is Anti-VEGF?
Anti-VEGF 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
- This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab/tuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 70
You may be able to join if
- Male or female patients aged between 18 and 70 years.
- Unresectable HCC, BCLC Stage C according to the BCLC strategy-2025 update, with staging established via biopsy pathology and/or clinical diagnosis.
- Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Metastatic burden and SBRT eligibility
- Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions
You likely can't join if
- Histopathological exclusions
- Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components
- Curative local therapy candidacy
- Current candidacy for resection, liver transplant, or RFA
- RT infeasibility
- Prior radioembolization
See the full eligibility criteria
- Male or female patients aged between 18 and 70 years.
- Unresectable HCC, BCLC Stage C according to the BCLC strategy-2025 update, with staging established via biopsy pathology and/or clinical diagnosis.
- Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Metastatic burden and SBRT eligibility
- Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions
- All intended intrahepatic and/or extrahepatic SBRT targets must satisfy protocol-specified target-coverage, liver reserve, and organ-at-risk (OAR) constraints within a composite 5-fraction plan
- Prognosis \& measurable disease
- Life expectancy ≥3 months
- ≥1 measurable lesion (per RECIST 1.1):
- Tumor: ≥10 mm (CT long axis)
- Lymph node: ≥15 mm (CT short axis)
- Prior therapy
- Prior locoregional therapy permitted：radiofrequency ablation (RFA), TACE, or HAIC, provided that:
- Documented radiographic progression or intolerance after the prior therapy
- Washout ≥28 days
- Treatment-related toxicities recovered to ≤Grade 1 (alopecia and peripheral neuropathy ≤Grade 2 allowed)
- Laboratory and virologic requirements
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN); total bilirubin ≤3 × ULN; serum albumin ≥28 g/L
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min
- Urine dipstick protein \<2+; if baseline dipstick proteinuria is ≥2+, 24-hour urinary protein must be \<1 g
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN
- Histopathological exclusions
- Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components
- Curative local therapy candidacy
- Current candidacy for resection, liver transplant, or RFA
- RT infeasibility
- Prior radioembolization
- Single liver tumor ≥15 cm or total intrahepatic tumor diameter ≥20 cm
- more than 5 discrete intrahepatic parenchymal foci are present
- direct tumor extension into the stomach, duodenum, small bowel, or large bowel
- measurable common or main-branch biliary duct involvement
- Prior liver radiotherapy that would result in excessive overlap with the planned treatment fields
- Prior systemic therapies
- Received targeted-immunotherapy for HCC (e.g., PD-(L)1 inhibitors + tyrosine kinase inhibitors (TKIs))
- Prior immunotherapy: anti-PD-(L)1/CTLA-4 or chimeric antigen receptor T-cell therapy
- Hemorrhage/portal hypertension and hepatic decompensation risk
- Variceal bleeding within 6 months.
- Untreated or high-risk esophagogastric varices (e.g., grade ≥2 on endoscopy within 3 months) or other clinical evidence of portal hypertension with high bleeding risk per investigator.
- Moderate or severe ascites
- History of or active hepatic encephalopathy
- History of hemoptysis (≥2.5 mL of bright red blood per episode) within 28 days before study treatment
- Evidence of bleeding diathesis or significant coagulopathy
- Current or recent (within 10 days before study treatment) use of aspirin (≥325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, or therapeutic-dose oral/parenteral anticoagulants or thrombolytic agents
- Allergy to any component of iparomlimab/tuvonralimab or bevacizumab
- Comorbidities
- Active autoimmune disease or a history of autoimmune or inflammatory disease that may relapse; exceptions include hypothyroidism controlled with hormone replacement only, controlled celiac disease, and skin disorders...
- Any condition requiring systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days before study treatment
- Active or uncontrolled infection, including tuberculosis, or known HIV infection
- Prior allogeneic stem cell transplantation or organ transplantation
- Inadequately controlled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure \>90 mmHg despite optimal medical management, or a history of hypertensive crisis or hypertensive...
- History within 6 months before study treatment of myocardial infarction, unstable angina, symptomatic heart failure (New York Heart Association class ≥II), cerebrovascular accident, transient ischemic attack, pulmonary...
- Major surgical procedure within 28 days before study treatment, or serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
- History within 6 months before study treatment of gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, 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.