Actively Recruiting
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Led by Shandong Cancer Hospital and Institute · Updated on 2026-05-08
54
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.
CONDITIONS
Official Title
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged between 18 and 70 years
- Diagnosed with unresectable hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) Stage C confirmed by biopsy or clinical diagnosis
- Child-Pugh class A liver function without significant hepatic decompensation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Extrahepatic oligometastatic disease involving 3 or fewer organs and 5 or fewer total metastatic lesions
- All intended stereotactic body radiotherapy (SBRT) targets must meet protocol-specified coverage and organ safety criteria
- Life expectancy of at least 3 months
- At least one measurable lesion (tumor ≥10 mm or lymph node ≥15 mm by CT scan)
- Prior locoregional therapy allowed if there is documented progression or intolerance, with at least 28 days washout and recovery from treatment-related toxicities to Grade 1 or less (except alopecia and peripheral neuropathy allowed up to Grade 2)
- Laboratory values within specified limits including liver enzymes ≤5× upper limit of normal (ULN), total bilirubin ≤3× ULN, serum albumin ≥28 g/L, creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min, urine protein dipstick <2+ (or 24-hour protein <1 g if dipstick ≥2+), and coagulation tests (INR and aPTT) ≤1.5× ULN
You will not qualify if you...
- Mixed hepatocellular carcinoma subtypes such as fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma components
- Candidates currently eligible for curative therapies including resection, liver transplant, or radiofrequency ablation
- Prior radioembolization treatment
- Single liver tumor 15 cm or larger, or total intrahepatic tumor diameter 20 cm or larger
- More than 5 discrete intrahepatic tumor sites
- Tumor extension into stomach, duodenum, small bowel, or large bowel
- Measurable common or main-branch biliary duct involvement
- Prior liver radiotherapy that overlaps excessively with planned treatment areas
- Previous targeted immunotherapy for HCC, including PD-(L)1 inhibitors plus tyrosine kinase inhibitors
- Previous immunotherapy with anti-PD-(L)1/CTLA-4 or chimeric antigen receptor T-cell therapy
- Recent variceal bleeding within 6 months or high-risk varices with bleeding risk
- Moderate or severe ascites
- History of or active hepatic encephalopathy
- Hemoptysis with ≥2.5 mL bright red blood within 28 days before treatment
- Bleeding disorders or significant coagulopathy
- Recent use of aspirin (>325 mg/day), antiplatelet agents, or therapeutic anticoagulants within 10 days before treatment
- Allergy to iparomlimab/tuvonralimab or bevacizumab components
- Active autoimmune or inflammatory diseases that may relapse, except controlled hypothyroidism, celiac disease, or mild skin disorders
- Use of systemic corticosteroids >10 mg prednisone or equivalent within 14 days before treatment
- Active or uncontrolled infections including tuberculosis or HIV
- Prior allogeneic stem cell or organ transplantation
- Uncontrolled hypertension or history of hypertensive crisis or encephalopathy
- Recent myocardial infarction, unstable angina, heart failure, stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or serious thromboembolic events within 6 months
- Major surgery within 28 days before treatment or serious non-healing wounds
- Recent gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess within 6 months before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jinbo Yue, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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