OncoMatch/Clinical Trials/NCT07062055
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Is NCT07062055 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Anti-VEGF and Immunotherapy for hepatocellular carcinoma.
Treatment: Anti-VEGF · Immunotherapy — 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 multidisciplinary team (MDT) evaluation for surgical resection or 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), and evaluate the conversion rate to surgical resectability, 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC STAGE C (other)
Unresectable HCC, BCLC Stage C according to the BCLC strategy-2026 update
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: targeted-immunotherapy for hcc
Cannot have received: immunotherapy
Cannot have received: radioembolization
Lab requirements
Blood counts
INR and aPTT ≤1.5 × ULN
Kidney function
Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min
Liver function
Child-Pugh class A without clinically significant hepatic decompensation; AST, ALT, ALP ≤5 × ULN; total bilirubin <3 × ULN; serum albumin ≥28 g/L
Child-Pugh class A without clinically significant hepatic decompensation; AST, ALT, ALP ≤5 × ULN; total bilirubin <3 × ULN; serum albumin ≥28 g/L; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min; INR and aPTT ≤1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07062055 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior targeted-immunotherapy for hcc, immunotherapy, radioembolization disqualifies patients from enrollment.
What disease stage is eligible?
Stage BCLC STAGE C is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages