ClinicalTrialsFinder
RecruitingPhase 2NCT07062055

BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases

Bevacizumab Plus Iparomlimab/Tuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Thrombus and/or Extrahepatic Oligometastases (BITS-TO-HCC): Study Protocol of a Prospective, Multicenter, Single-Arm, Phase II Study

Sponsor

Shandong Cancer Hospital and Institute

Enrollment

54 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatocellular CarcinomaRadiotherapyImmunotherapyOligometastasesPortal Vein Tumor ThrombusHepatic Artery Infusion Chemotherapy

Summary

This multicenter, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining bevacizumab plus iparomlimab/tuvonralimab with hepatic artery infusion chemotherapy (HAIC) 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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (called BRAVE) tests a combination of an immunotherapy drug (QL1706), a blood vessel-blocking drug (bevacizumab), and targeted radiation (SBRT) for people with advanced liver cancer that has spread into blood vessels or formed a small number of tumors in other organs. **You may be eligible if...** - You are between 18 and 70 years old - You have advanced liver cancer (hepatocellular carcinoma, or HCC) confirmed by biopsy or clinical diagnosis - Your cancer has grown into a major liver vein (portal vein tumor thrombus) or has spread to 5 or fewer tumors in 3 or fewer organs outside the liver - Your liver function is relatively preserved (Child-Pugh class A or B, score 7 or less) - You have at least one tumor that can be measured on imaging - You have not received prior treatment for your liver cancer **You may NOT be eligible if...** - You have received prior treatment for liver cancer - Your liver function is poor - You have widespread cancer beyond the defined criteria Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your DoctorCheck Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAnti-VEGF

Drug: Bevacizumab (15 mg/kg, IV, every 3 weeks)

DRUGImmunotherapy

Iparomlimab/tuvonralimab (7.5 mg/kg, IV, every 3 weeks, administered sequentially after bevacizumab)

RADIATIONLocal Therapy

Stereotactic Body Radiotherapy (SBRT), total dose of 25-40 Gy in 5 fractions over 1-2 weeks, targeting intrahepatic tumors, portal vein tumor, and/or limited extrahepatic oligometastatic lesions

PROCEDUREhepatic arterial infusion chemotherapy (HAIC)

On Day 1 of each cycle, HAIC using the HAIC-FO regimen will be initiated via a hepatic arterial catheter or pump and completed over 2-3 days, as follows: oxaliplatin 130 mg/m², leucovorin 200 mg/m², fluorouracil 400 mg/m² as a bolus, followed by fluorouracil 2,400 mg/m² by continuous infusion over 46 h. HAIC may be administered every 3 weeks for up to four cycles.

Locations(1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07062055

Related Trials

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

NCT0609677961 locations

An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer

NCT063424145 locations

Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC

NCT0573359812 locations

Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC

NCT065538851 location

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

NCT0676431612 locations