Actively Recruiting
Bevacizumab Plus Iparomlimab/Tuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy for Advanced Liver Cancer With Portal Vein Tumor Thrombus or Oligometastases (BITS-TO-HCC) Phase II Study
Led by Shandong Cancer Hospital and Institute · Updated on 2026-05-08
54
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination treatment for patients with advanced liver cancer known as Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC), specifically those with portal vein tumor thrombus (PVTT) or limited spread outside the liver (oligometastases). This Phase II study aims to see if combining hepatic artery infusion chemotherapy (HAIC) with immunotherapy drugs iparomlimab/tuvonralimab and bevacizumab, followed by focused radiotherapy, can improve survival and disease control while maintaining quality of life and safety. The treatment includes up to four cycles of HAIC, where chemotherapy drugs are delivered directly into the liver artery over 2-3 days every three weeks. Alongside this, patients receive intravenous bevacizumab every three weeks, followed by iparomlimab/tuvonralimab, also every three weeks. After these cycles, patients undergo stereotactic body radiotherapy (SBRT) delivering 25-40 Gy in 5 sessions over 1-2 weeks to target tumors in the liver, portal vein, or limited extrahepatic lesions. The regimen is designed to act together to reduce tumor burden and enhance immune response. Participants will be closely monitored through various assessments during and after treatment, including imaging to measure tumor response and disease progression over at least two years. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, disease control, local tumor control, adverse events, and quality of life changes. The study will evaluate safety and treatment-related side effects over five years, with detailed follow-up to assess long-term outcomes of this combined approach.
CONDITIONS
Brief 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
- Diagnosis of unresectable hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C
- Child-Pugh class A liver function without significant hepatic decompensation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Extrahepatic oligometastatic disease limited to 3 or fewer organs and 5 or fewer total metastatic lesions
- Suitable for stereotactic body radiotherapy (SBRT) with protocol-defined dosing and organ-at-risk constraints
- Life expectancy of at least 3 months
- At least one measurable tumor lesion (tumor ≥10 mm or lymph node ≥15 mm by CT scan)
- Prior locoregional therapies like radiofrequency ablation, TACE, or HAIC allowed if progressive or intolerant with adequate recovery
- Laboratory values within specified limits for liver enzymes, bilirubin, albumin, creatinine, proteinuria, coagulation tests
You will not qualify if you...
- Mixed liver cancer types such as fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma components
- Candidates currently eligible for curative surgery, liver transplant, or radiofrequency ablation
- Prior radioembolization treatment
- Large liver tumors (single tumor ≥15 cm or total tumors ≥20 cm) or more than 5 intrahepatic tumor sites
- Tumor extension into digestive organs or major bile ducts
- Prior liver radiotherapy causing excessive overlap with planned treatment
- Previous targeted immunotherapy or specific immunotherapies like anti-PD-(L)1/CTLA-4 or CAR T-cell therapy
- Recent variceal bleeding or high-risk untreated esophagogastric varices
- Moderate or severe fluid buildup in abdomen (ascites)
- History or active hepatic encephalopathy
- Recent significant bleeding events or blood clotting disorders
- Use of certain blood-thinning medications within 10 days before treatment
- Allergy to study drugs iparomlimab/tuvonralimab or bevacizumab
- Active autoimmune diseases or those needing systemic immunosuppression
- Active infections including tuberculosis or HIV
- Prior organ or stem cell transplantation
- Poorly controlled high blood pressure or recent serious cardiovascular events
- Recent major surgery or serious wounds
- Recent gastrointestinal perforation, fistula, or abscess
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 4 months (up to four 3-week cycles plus 1-2 weeks radiotherapy)
Participants receive hepatic artery infusion chemotherapy (HAIC) every 3 weeks for up to four cycles, along with intravenous bevacizumab and sequential iparomlimab/tuvonralimab administered every 3 weeks. After completing these drug treatments, participants undergo stereotactic body radiotherapy (SBRT) targeting liver tumors and/or metastatic lesions over 1 to 2 weeks.
HAIC and drug infusions every 3 weeks for up to 4 cycles; SBRT delivered in 5 fractions over 1-2 weeks
Duration - Up to 5 years
Participants are monitored for progression-free survival and safety outcomes after completing treatment.
Visits scheduled periodically during follow-up for up to 5 years
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jinbo Yue, doctor
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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