Trial · NCT05194293

Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer

NCT05194293, Phase 2, Active not recruiting, Academic and Community Cancer Research United

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer. Trials, record NCT05194293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05194293

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer
NCT number: NCT05194293
Status: Active not recruiting
Phases: Phase 2
Enrollment: 4 participants, actual
Lead sponsor: Academic and Community Cancer Research United
Conditions: Stage IB Hepatocellular Carcinoma AJCC v8, Stage II Hepatocellular Carcinoma AJCC v8, Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Interventions: Durvalumab, Regorafenib
First posted: 2022-01-18
Last updated: 2026-07-20

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR) (Unconfirmed)	16 weeks	An objective response is defined as a complete response (CR) or partial response (PR). Disease status will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 criteria. ORR is defined as the proportion of evaluable patient who experience a CR or PR divided by the total number of evaluable patients. The final ORR point estimate and corresponding 95% confidence interval will be reported.
Secondary	Rate of Surgery During the Course of the Study	10 months	The proportion of patients who underwent surgery within 4 months of the last treatment dose during the course of the study. The 95% confidence interval calculated by Clopper and Pearson will be reported.
Secondary	Number of Patients Experiencing Adverse Events	2 years	The rate of patients experiencing a grade 3+ adverse event will be reported. Further analyses of adverse event rates will be considered exploratory.
Secondary	Progression-free Survival (PFS)	2 years	PFS is defined as the time from registration to the first of either disease progression or death from any cause, where disease progression is determined based on RECIST 1.1 criteria. Patients who do not experience disease progression or death while on protocol will be censored at the last disease assessment date. PFS will be estimated using the Kaplan-Meier method. Patients in the primary evaluable population who are not in the resectable evaluable population will be eligible for the analysis of this endpoint. The median PFS and corresponding 95% confidence interval (by Brookmeyer and Crowley) will be reported.
Secondary	Overall Survival (OS)	2 years	OS is defined as the time from registration to death from any cause. Patients who are alive will be censored at the last follow-up date. OS will be estimated using the Kaplan-Meier method. Patients in the primary evaluable population will be eligible for the analysis of this endpoint.. The median OS and corresponding 95% confidence interval (by Brookmeyer and Crowley) will be reported.
Secondary	Recurrence-free Survival (RFS)	2 years	RFS is defined as the time from surgical resection to first of either disease recurrence or death from any cause. Patients who do not experience disease recurrence or death while on protocol will be censored at the last disease assessment date. RFS will be estimated using the Kaplan-Meier method. The resectable evaluable population will be used for the analysis of this endpoint. The median RFS and corresponding 95% confidence interval (by Brookmeyer and Crowley) will be reported.
Secondary	Pathologic Complete Response Rate	10 months	A pathologic complete response must satisfy all of the following: \No metastatic disease (i.e. pM0 or pMx, pNo or pNx) \Zero percent residual tumor cells in the specimen including the presumed prior tumor bed and elsewhere \*Negative resection margin on all margin examined. The proportion of patients experiencing pathologic complete response and corresponding 95% confidence interval will be reported.
Other	Immune Biomarkers	Analyze the effect of regorafenib and durvalumab on immune biomarkers in the tumor microenvironment and systemic circulation At baseline, week 8, 12, 20, and at off protocol treatment

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.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA015083	Mayo Clinic Comprehensive Cancer Center Support Grant	WILLMAN, CHERYL LYNN	MAYO CLINIC ROCHESTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT05194293

GET https://conductscience.org/api/trials/v1/NCT05194293/registered

API reference For AI assistants