Trial · NCT04718909
Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC
NCT04718909, Phase 2, Unknown, Second Affiliated Hospital of Guangzhou Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC. Trials, record NCT04718909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04718909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC
- NCT number
- NCT04718909
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 166 participants, actual
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Interventions
- Regorafenib + sintilimab, Regorafenib
- First posted
- 2021-01-22
- Last updated
- 2022-11-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST) | 24 months | The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first. |
| Secondary | Adverse Events (AEs) | 24 months | Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0. |
| Secondary | Overall survival (OS) | 24 months | The time from date of randomization to death due to any cause. |
| Secondary | Time to Progression (TTP) assessed by investigators according to RECIST 1.1 and irRECIST | 24 months | The time from date of randomization until the first occurrence of disease progression. |
| Secondary | Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST. | 24 months | The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR). |
| Secondary | Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST | 24 months | The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD). |
| Secondary | PFS assessed by investigators according to Modified RECIST (mRECIST) | 24 months | The time from date of randomization until the first occurrence of disease progression or death due to any cause, whichever occurs first. |
| Secondary | TTP assessed by investigators according to mRECIST. | 24 months | The time from date of randomization until the first occurrence of disease progression. |
| Secondary | ORR assessed by investigators according to mRECIST | 24 months | The percentage of patients who had a best overall tumor response rating of CR or PR. |
| Secondary | DCR assessed by investigators according to mRECIST. | 24 months | The percentage of patients who had a tumor response rating of CR, PR, or SD. |
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/NCT04718909
GET https://conductscience.org/api/trials/v1/NCT04718909/registered