Trial · NCT04183088
Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular Carcinoma
NCT04183088, Phase 2, Unknown, National Taiwan University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular Carcinoma. Trials, record NCT04183088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04183088
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular Carcinoma
- NCT number
- NCT04183088
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 125 participants, estimated
- Lead sponsor
- National Taiwan University Hospital
- Conditions
- Advanced Hepatocellular Carcinoma
- Interventions
- Tislelizumab+regorafenib for part 1;Tislelizumab+regorafenib for group 1 of part 2; Regorafenib for group 2 of part 2.
- First posted
- 2019-12-03
- Last updated
- 2020-12-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety cohort: 14 participants with treatment related serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V5.0. | Day 1, Change from Day 1 to 23-37 days after the last dose of study drug treatment. | 14 or fewer participants who experience grade 3 or greater treatment-related adverse events at the 80 mg per day level, as defined by Common Terminology Criteria for Adverse Events (CTCAE)V5.0. |
| Primary | Randomized cohorts: Objective response rate (ORR) (co-primary) | about 1 year | The percentage of 100 participants with radiologically complete or partial response as determined by the investigator according to Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) |
| Primary | Randomized cohorts: Progression-free survival (PFS) (co-primary) | about 1 year | PFS is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). |
| Secondary | Safety cohort: safety as assessed by 25 participants experiencing who incidence and severity of total AE, liver related AE, and immune-related AE. | Day 1, Change from Day 1 to 23-37 days after the last dose of study drug treatment. | 25 participants experiencing who incidence and severity of total AE, liver related AE, and immune-related AE.as defined by Common Terminology Criteria for Adverse Events (CTCAE)V5.0. |
| Secondary | Safety cohort: Proportion of 25 participants who may escalate the dose of regorafenib (continuous dosing) during study drug treatment | Day 1 of each cycle | An adequate supply of regorafenib will be dispensed to participants on Day 1 of each new cycle (once every 3 weeks). Each time study drug is dispensed, compliance will be evaluated and encouraged. Treatment compliance will also be monitored by drug accountability log. |
| Secondary | Safety cohort: Objective response rate (ORR) | about 1 year | The percentage of 25 participants with radiologically complete or partial response as determined by the investigator according to both RECIST 1.1 and the immune-RECIST. |
| Secondary | Randomized cohort: safety as assessed by 100 participants experiencing who incidence and severity of total AE, liver related AE, and immune-related AE. | Day 1, Change from Day 1 to 23-37 days after the last dose of study drug treatment. | 100 participants experiencing who incidence and severity of total AE, liver related AE, and immune-related AE.as defined by Common Terminology Criteria for Adverse Events (CTCAE)V5.0. |
| Secondary | Randomized cohort: Objective response rate (ORR) | about 1 year | The percentage of 100 participants with radiologically complete or partial response as determined by the investigator according to both RECIST 1.1 and the immune-RECIST. |
| Secondary | Safety cohort: progression-free survival (PFS) | about 1 year | PFS is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1 and the immune-RECIST or death from any cause (whichever occurs first). |
| Secondary | Randomized cohort: progression-free survival (PFS) | about 1 year | PFS is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1 and the immune-RECIST or death from any cause (whichever occurs first). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04183088
GET https://conductscience.org/api/trials/v1/NCT04183088/registered