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RecruitingNCT05811481ROSEUpdated Apr 13, 2023

Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy

An observational study in Hepatocellular Carcinoma, Transcatheter Arterial ChEmoembolization and Regorafenib, sponsored by WenBo Guo. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by WenBo Guo · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
192
Ages
18 Years to 75 Years
Sex
All
01

Study summary

. 1 Clarify the difference in efficacy of regofinib combined with TACE compared with second-line treatment of advanced liver cancer; 2. To evaluate the safety and prognostic imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it is necessary to increase the treatment of TACE in the second-line treatment of advanced HCC.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Transcatheter Arterial ChEmoembolization
  • Regorafenib
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 192 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with WenBo Guo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with hepatocellular carcinoma

Inclusion criteria

( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic recurrence before (including a); ( - ) Previous failure of first-line systemic treatment; ( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At least one measurable lesion in the liver.

Exclusion criteria

Exclusion Criteria:

( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy, radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the second-line systemic treatment, I also received local treatment, systemic chemotherapy, radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to any drug included in the study; ( - ) Pregnant or lactating women;

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
192 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Two treatment groups

    Regorafenib + TACE

    Procedure: TACE · Drug: Regorafenib

  • Treatment ate group

    Regorafinib

    Drug: Regorafenib

Interventions

  • ProcedureTACE

    Transcatheter Arterial Chemoembolization

  • DrugRegorafenib

    Regorafenib alone

06

What researchers measure

Primary outcomes

  1. Overall survival

    defined as the time between the start of second-line treatment and the end of follow-up / death.

    Time frame: 2022.12.27-2025.09.30

Secondary outcomes

  1. Progression-free survival for the first subsequent treatment PFS 2

    defined as the time of second-line treatment initiation to the date of radiological progression or death from any cause.

    Time frame: 2022.12.27-2025.09.30

07

Study locations

1 of 1 sites recruiting
  • FirstSunYetSen
    Guangzhou, Guangdong 510200, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Regorafenib Alone or in Combined with Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma after First Line Targeted Therapy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05811481
Lead sponsor
WenBo Guo
Responsible party
WenBo Guo (professor, First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Apr 13, 2023
Start date
Dec 27, 2022
Primary completion
Dec 27, 2024 (estimated)
Completion
Dec 27, 2025 (estimated)
Last update
Apr 13, 2023

Study contacts

WenBo Guo
Contact
patrickguo2008@163.com
+8613922282028

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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