BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-70 lat
- •Zaawansowany rak wątroby (stadium BCLC C), który nie może być operowany
- •Sprawność fizyczna dobra (0-1 w skali ECOG) i dobra funkcja wątroby (klasa Child-Pugh A)
- •Przerzuty poza wątrobą w 3 lub mniej narządach (maksymalnie 5 guzów)
- •Spodziewana długość życia co najmniej 3 miesiące
- •Co najmniej jeden mierzalny guz (10 mm i większy)
- •Poprzednie leczenie lokalne dopuszczalne, jeśli minie 28 dni i guzy się rozwijały
- •Prawidłowe wyniki badań krwi (funkcja wątroby i nerek)
✗ Disqualifies
- •Mieszane typy histologiczne raka wątroby (włóknisto-płytkowy, sarkomatoidalny) lub rak przewodów żółciowych
- •Kwalifikacja do operacji wyleczniczej, przeszczepu wątroby lub do innego aktywnego leczenia onkologicznego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- September 4, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Shandong Cancer Hospital and Institute
Jinan, China
Trial contact
Jinbo Yue, doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/5/2026.
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