What is this study trying to find out about hepatocellular carcinoma?

This study is evaluating whether a combination of chemotherapy delivered directly to the liver, immunotherapy drugs, and targeted radiotherapy can improve outcomes in advanced liver cancer patients with specific complications. Researchers want to see if this approach can extend the time without disease progression and improve survival while maintaining quality of life. The study is sponsored by Shandong Cancer Hospital and Institute.

Who may be eligible for this hepatocellular carcinoma clinical trial?

Adults aged 18 to 70 years with unresectable liver cancer classified as BCLC stage C may be eligible. Participants must have good liver function (Child-Pugh class A) and performance status, and must not have received certain prior immunotherapies. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this hepatocellular carcinoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 70Years

All Genders

ID07062055

Bevacizumab Plus IparomlimabTuvonralimab 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

Participants Needed

Research Sites

52 weeks

Total Duration

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 iparomlimabtuvonralimab 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 iparomlimabtuvonralimab, 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

Age: 18Years - 70Years

All Genders

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

Research Team

Jinbo Yue, doctor

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