deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT03468231

HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis

Sponsor: Dongguan People's Hospital

Conditions Hepatocellular Carcinoma
Interventions HAIC of FOLFOX HAIC of OXA Sorafenib
Updated 8 times since 2018 Last updated: Mar 11, 2018 Started: Mar 9, 2018 Primary completion: Sep 9, 2019 Completion: Mar 9, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hepatocellular Carcinoma and is currently ongoing. Dongguan People's Hospital leads this study, which shows 8 recorded versions since 2018 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Status Flow

~Apr 2018 – ~Nov 2018 · 7 months · monthly snapshotRecruiting~Nov 2018 – ~Apr 2020 · 17 months · monthly snapshotRecruiting~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded

  1. Jan 2026 — Present [monthly]

    Unknown PHASE3

  2. Sep 2025 — Present [monthly]

    Unknown PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown Status → Unknown

  5. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

▶ Show 3 earlier versions

  1. Apr 2020 — Jan 2021 [monthly]

    Unknown Status PHASE3

    Status: Recruiting → Unknown Status

  2. Nov 2018 — Apr 2020 [monthly]

    Recruiting PHASE3

  3. Apr 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

    First recorded

Mar 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dongguan People's Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital, Sun Yat-Sen University
  • Guangzhou No.12 People's Hospital
  • Kaiping Central Hospital
  • Sun Yat-sen University
  • The First Affiliated Hospital of University of South China
Data source: Sun Yat-sen University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations