deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01015833

Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Sponsor: National Cancer Institute (NCI)

Conditions Advanced Adult Hepatocellular Carcinoma Recurrent Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v7 Stage IIIA Hepatocellular Carcinoma AJCC v7 Stage IIIB Hepatocellular Carcinoma AJCC v7 Stage IIIC Hepatocellular Carcinoma AJCC v7 Stage IV Hepatocellular Carcinoma AJCC v7 Stage IVA Hepatocellular Carcinoma AJCC v7 Stage IVB Hepatocellular Carcinoma AJCC v7 Unresectable Hepatocellular Carcinoma
Interventions Doxorubicin Hydrochloride Laboratory Biomarker Analysis Pharmacogenomic Study Sorafenib Tosylate
Updated 46 times since 2017 Last updated: Aug 3, 2022 Started: Feb 15, 2010 Primary completion: May 21, 2015 Completion: Aug 15, 2018
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 Advanced Adult Hepatocellular Carcinoma and Recurrent Hepatocellular Carcinoma and is currently completed. National Cancer Institute (NCI) leads this study, which shows 46 recorded versions since 2010 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Sep 2017 · 7 months · monthly snapshot~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~May 2021 · 3 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Jan 2022 · 3 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

46 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

▶ Show 41 earlier versions

  1. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  2. Apr 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  3. Mar 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE3

  4. Feb 2022 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2022 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  6. Oct 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  8. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  13. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  14. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  15. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  16. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  17. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  18. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  19. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  20. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  21. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  22. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE3

  23. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  24. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  25. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  26. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  27. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  28. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  29. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  30. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  31. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  32. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  33. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  34. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  35. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  36. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

  37. Aug 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE3

  38. Jun 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE3

  39. Sep 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  40. Feb 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE3

  41. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Feb 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations

Abington, United States , Adrian, United States , Akron, United States , Albuquerque, United States , Allentown, United States , Altamonte Springs, United States , Amarillo, United States , Ames, United States , Anacortes, United States , Anaheim, United States and 384 more locations