Hepatocellular CarcinomaPhase 2ReDos HCCNCT04476329
Optimization for Regorafenib in HCC
A Phase 2 study testing Regorafenib 40 MG in people with Hepatocellular Carcinoma, run by SC Liver Research Consortium, LLC at 9 sites in United States.
Trial summary
This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Regorafenib 40 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Jan 2021to 10 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age ≥ 18 years.
- Histological, cytological confirmation of hepatocellular carcinoma or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
- Locally advanced or metastatic and/or unresectable HCC that is not amenable or progressed after curative surgical and/or locoregional therapies.
- Patients who received one prior systemic treatment and for whom the treating physician has decided to treat with regorafenib.
- Life expectancy of ≥ 3 months.
- The following laboratory values obtained ≤ 7 days prior to randomization.
Show all 20Show fewer
- Absolute neutrophil count (ANC) > 1500/mm3
- Platelet count > 60,000/mm3
- Hemoglobin > 9.0 g/dL
- Albumin > 2.7 gm/dL
- Total bilirubin < 2 mg/dl (Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert's syndrome is documented)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula)
- INR/PTT ≤ 1.5 x ULN
- Alkaline phosphatase limit ≤ 2.5 x ULN
- At least one measurable (per RECIST 1.1) lesion. Patients who received prior local therapy (e.g., radiofrequency ablation or transarterial chemoembolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) = 0 or 1
- Negative serum pregnancy test done ≤ 7 days prior to randomization, for females of childbearing potential only.
- Provide written informed consent.
- Patients with a prior liver transplant may be included if they have no history of graft rejection within the previous 6 months and stable graft function.
Who cannot join
- Prior treatment with regorafenib.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization.
- Congestive heart failure > New York Heart Association (NYHA) class 2.
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 6 months prior to randomization.
- Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: beta blockers or digoxin are permitted.
- Uncontrolled hypertension. (Systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
Show all 32Show fewer
- History of or current pheochromocytoma.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism ≤ 6 months prior to randomization.
- Ongoing infection > grade 2 NCI-CTCAE version 5.0.
- Patients with seizure disorder requiring medication.
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization.
- NOTE: Patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
- History of organ allograft (including corneal transplant), except prior liver transplant.
- Hepatic Encephalopathy requiring hospital admission within six (6) months prior to randomization.
- Ascites requiring paracentesis within four (4) weeks of randomization.
- Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE grade 3 ≤4 weeks prior to randomization.
- Non-healing wound, ulcer, or bone fracture.
- Renal failure requiring hemo-or peritoneal dialysis.
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
- Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
- Patients unable to swallow oral medications.
- Any malabsorption conditions that will affect that absorption of regorafenib.
- Unresolved toxicity greater than CTCAE (version 5.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity ≤ Grade 2.
- Pregnant or nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception because regorafenib is a chemotherapeutic agent that has known genotoxic, mutagenic, and teratogenic effects.
- NOTE: Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial. Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS)-related illness 29. Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE version 4.0 Grade 2 dyspnea).
- 30. Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib).
- 31. Use of any herbal remedies known to have interference with liver or other major organ functions. Patients must notify the investigator of all herbal remedies used during the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Henry Ford Health Systems
Detroit, Michigan, 48202
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89014
VA Long Beach Health System
Long Beach, California, 90822
Tulane University
New Orleans, Louisiana, 70112
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Saint Louis University
St Louis, Missouri, 63104
About this study
Official title: A Randomized Phase II Study of First Cycle Optimization for Regorafenib Treatment Compared to Standard Dose of Regorafenib in Patients With HCC Who Failed Any 1st Line Systemic Treatment and for Whom the Physician is Intending to Treat With Regorafenib
This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment.
Read the detailed description
In this study, the investigators intend to evaluate the regorafenib ReDOS strategy to optimize the dose of regorafenib in patients with unresectable HCC (uHCC) who progressed during or after the first-line systemic treatment. This would allow improving the tolerability profile for patients such as those not selected based on prior sorafenib tolerability. The proposed regorafenib dosing escalation strategy for subjects randomized to the Arm A starting 80 mg/day dose for one week (Cycle 1, Week 1) is, if absent significant drug-related toxicities, to escalate to 120 mg/day for another week (Cycle 1, Week 2), and then, again if absent significant related toxicities, escalate to a total dose of 160 mg/day (Cycle 1, Week 3) followed by a week-long break (Cycle 1, Week 4).
Arm B, the comparative arm, will include a standard dose/schedule regorafenib of a 160 mg/day starting on Cycle 1, Day 1. The primary goal of this Arm is compare whether, or not, an 80 mg/day starting dose of regorafenib that escalates weekly by 40 mg until 160 mg/day is non-inferior to the FDA approved labeling 160 mg starting dose of regorafenib in terms of Overall Survival (OS) in HCC subjects. The investigators will also compare the proportions of patients in each arm who complete two cycles of treatment and who intend to continue to a third cycle if no tumor progression is noted on the 8-week disease scan. Other outcomes such as Quality of Life measures, and toxicity profile with a focus on regorafenib related toxicities such as hand-foot skin reaction will also be assessed.
Patients will be randomized 1:1 to either Arm A receiving the Cycle 1 Week-1 80 mg daily dose or Arm B the standard FDA labeling 160 mg daily starting dose, with subsequent dose adjustments as needed. Patients with unacceptable toxicities at the 80 mg dose may be considered for further dose reduction but will no longer be included in the overall survival analysis. After the conclusion of Cycle 2 (Week 8 of treatment), if toxicities have sufficiently resolved, re-escalation is allowed 40 mg at a time every four weeks to a maximum of 160 mg/day at the discretion of the treating investigator.
Patients will continue treatment until progression, unacceptable adverse events, or patient refusal. Treatment will then be discontinued, and the patient will go to event monitoring.
Additionally, a site-optional and subject-optional sub-study collecting blood serum samples at the Screening Visit for "hold and store" for future analysis of CD14, CD15, and CD16 cells as well as other potential biomarkers to be determined.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Regorafenib 40 MG
- Keywords
- Hepatocellular carcinoma, Liver Cancer, HCC, Regorafenib, Sorafenib, Stivarga
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib 40 MGDrug
Also called Stivarga
Regorafenib (BAY 73-4506) is an oral small molecule tyrosine kinase inhibitor (TKI) that potently blocks multiple protein kinases, including kinases involved in tumor angiogenesis (vascular endothelial growth factor receptor [VEGFR] 1, 2, 3, Tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 [TIE2]), stem cell growth factor receptor (KIT, rearranged during transfection [RET], p38-alpha, a member of the mitogen activated protein kinase [MAPK] family, proto-oncogene c-RAF [c-RAF], proto-oncogene BRAF [BRAF], BRAFV600E), metastasis (VEGFR3, platelet-derived growth factor receptor [PDGFR], fibroblast growth factor receptor1 [FGFR1]) and tumor immunity (colony stimulating factor 1 receptor [CSF1R]).
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Arm A: Regorafenib Cycle 1:
* 80 mg daily Week 1
* 120 mg daily Week 2
* 160 mg daily week 3 then 1 week off followed by Cycle 2+ (160 mg for 21 days/1 week off) Subsequent Treatment Cycles
* 160 mg daily for 21 days, then 1 week off. Receives: Drug: Regorafenib 40 MG |
| B | Active comparator | Arm B: Regorafenib Cycle 1:
* 160 mg daily for 21 days/then 1 week off Subsequent Treatment Cycles
* 160 mg daily for 21 days, then 1 week off Receives: Drug: Regorafenib 40 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The primary objective is to evaluate whether, or not, an 80 mg/day starting dose of regorafenib that escalates weekly by 40 mg until 160 mg/day is non-inferior compared to the FDA approved labeling 160 mg starting dose of regorafenib in terms of Overall Survival in HCC subjects.
Measured: 24 months
Secondary outcomes (6)
Regorafenib treatment cycles
Proportion of patients who complete two cycles of treatment and who intend to initiate Cycle 3 if no progression is noted on the planned 8-week scan
Measured: 24 months
Tumor Progression
Progression-free survival (PFS) per RECIST v1.1 with exploratory analysis of progression-free survival (PFS) per mRECIST where available
Measured: 24 months
Dosing Patterns
Evaluate the dosing schedule of regorafenib treatment, including: cumulative doses received during first and second cycles, duration of treatment (DOT) measured from Cycle 1 Day 1 to the 1 Month Follow-Up 30 days after the last dose of regorafenib, and summary of additional dose patterns or parameters such as the median daily dose for each treatment arm.
Measured: 24 months
EORTC QOL-C30 Quality of Life Measurements
The EORTC QOL-C30 Quality of Life questionnaire contains 30 questions around physical, day-to-day functioning, and side effects experienced measured on a 4 point Likert scale with a response range of "1-not at all," "2-a little bit," "3-quite a bit," and "4-very much." The results between the Arms, particularly for Cycle 1, will be compared.
Measured: 24 months
Optional CD14-16 cell sub-study
An optional sub-study, collect and hold blood samples from 100 subjects for analysis of mononuclear cells (CD14, 15 \& 16 cells) and other potential biomarkers at a to-be-determined time point after completion of the study.
Measured: 36 months
FACIT FACT-Hep Quality of Life Measurements
The FACT-Hep Quality of Life questionnaire contains 46 questions around physical, social/family, emotional, day-to-day functioning, and side effects experienced measured on a 5 point Likert scale with a response range of "0-not at all," "1-a little bit," "3-somewhat," "4-quite a bit," and "5-very much." The results between the Arms, particularly for Cycle 1, will be compared..
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start21 Jan 2021
- Primary completion13 Oct 2021
- Study completion10 Dec 2021
Why it stopped: Enrollment rate not sufficient to meet funding entity's corporation timeline expectations, entity terminated study's fiscal support. Termination decision was purely administrative in nature and did not involve drug or patient safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A will initiate Cycle 1 treatment at 80mg daily of regorafenib escalating up to but not exceeding 160mg daily at 40mg per week increments. Arm B will initiate Cycle 1 treatment at 160mg daily of regorafenib.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- SC Liver Research Consortium, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Catherine T Frenette, MD, Principal investigator, Scripps MD Anderson Cancer CenterMadappa Kundranda, MD, Principal investigator, Banner MD Andersen Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476329
- Sponsor's protocol ID
- 21305
- Acronym
- ReDos HCC
- Status last verified
- Dec 2021
- First submitted
- 14 Jul 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be available for review, analysis and reporting.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of First Cycle Optimization for Regorafenib Treatment Compared to Standard Dose of Regorafenib in Patients With HCC Who Failed Any 1st Line Systemic Treatment and for Whom the Physician is Intending to Treat With Regorafenib
- ClinicalTrials.gov ID
- NCT04476329
- Acronym / sponsor ID
- ReDos HCC / 21305
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Liver Cancer, HCC, Regorafenib, Sorafenib, Stivarga
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate not sufficient to meet funding entity's corporation timeline expectations, entity terminated study's fiscal support. Termination decision was purely administrative in nature and did not involve drug or patient safety issues.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- SC Liver Research Consortium, LLCUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, two arm, phase II study of 1st Cycle dose optimization for regorafenib treatment compared to standard dose of regorafenib treatment in HCC patients for whom the physician is intending to treat with regorafenib and who failed any 1st line systemic treatment.
Detailed description
In this study, the investigators intend to evaluate the regorafenib ReDOS strategy to optimize the dose of regorafenib in patients with unresectable HCC (uHCC) who progressed during or after the first-line systemic treatment. This would allow improving the tolerability profile for patients such as those not selected based on prior sorafenib tolerability. The proposed regorafenib dosing escalation strategy for subjects randomized to the Arm A starting 80 mg/day dose for one week (Cycle 1, Week 1) is, if absent significant drug-related toxicities, to escalate to 120 mg/day for another week (Cycle 1, Week 2), and then, again if absent significant related toxicities, escalate to a total dose of 160 mg/day (Cycle 1, Week 3) followed by a week-long break (Cycle 1, Week 4).
Arm B, the comparative arm, will include a standard dose/schedule regorafenib of a 160 mg/day starting on Cycle 1, Day 1. The primary goal of this Arm is compare whether, or not, an 80 mg/day starting dose of regorafenib that escalates weekly by 40 mg until 160 mg/day is non-inferior to the FDA approved labeling 160 mg starting dose of regorafenib in terms of Overall Survival (OS) in HCC subjects. The investigators will also compare the proportions of patients in each arm who complete two cycles of treatment and who intend to continue to a third cycle if no tumor progression is noted on the 8-week disease scan. Other outcomes such as Quality of Life measures, and toxicity profile with a focus on regorafenib related toxicities such as hand-foot skin reaction will also be assessed.
Patients will be randomized 1:1 to either Arm A receiving the Cycle 1 Week-1 80 mg daily dose or Arm B the standard FDA labeling 160 mg daily starting dose, with subsequent dose adjustments as needed. Patients with unacceptable toxicities at the 80 mg dose may be considered for further dose reduction but will no longer be included in the overall survival analysis. After the conclusion of Cycle 2 (Week 8 of treatment), if toxicities have sufficiently resolved, re-escalation is allowed 40 mg at a time every four weeks to a maximum of 160 mg/day at the discretion of the treating investigator.
Patients will continue treatment until progression, unacceptable adverse events, or patient refusal. Treatment will then be discontinued, and the patient will go to event monitoring.
Additionally, a site-optional and subject-optional sub-study collecting blood serum samples at the Screening Visit for "hold and store" for future analysis of CD14, CD15, and CD16 cells as well as other potential biomarkers to be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A will initiate Cycle 1 treatment at 80mg daily of regorafenib escalating up to but not exceeding 160mg daily at 40mg per week increments. Arm B will initiate Cycle 1 treatment at 160mg daily of regorafenib.
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Regorafenib 40 MGArm A: Regorafenib Cycle 1: * 80 mg daily Week 1 * 120 mg daily Week 2 * 160 mg daily week 3 then 1 week off followed by Cycle 2+ (160 mg for 21 days/1 week off) Subsequent Treatment Cycles * 160 mg daily for 21 days, then 1 week off. |
| B | Active comparator | Drug: Regorafenib 40 MGArm B: Regorafenib Cycle 1: * 160 mg daily for 21 days/then 1 week off Subsequent Treatment Cycles * 160 mg daily for 21 days, then 1 week off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients age ≥ 18 years.
- Histological, cytological confirmation of hepatocellular carcinoma or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
- Locally advanced or metastatic and/or unresectable HCC that is not amenable or progressed after curative surgical and/or locoregional therapies.
- Patients who received one prior systemic treatment and for whom the treating physician has decided to treat with regorafenib.
- Life expectancy of ≥ 3 months.
Key exclusion criteria (32 listed)
- Prior treatment with regorafenib.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization.
- Congestive heart failure > New York Heart Association (NYHA) class 2.
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction less than 6 months prior to randomization.
- Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: beta blockers or digoxin are permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib 40 MGAlso: StivargaRegorafenib (BAY 73-4506) is an oral small molecule tyrosine kinase inhibitor (TKI) that potently blocks multiple protein kinases, including kinases involved in tumor angiogenesis (vascular endothelial growth factor receptor [VEGFR] 1, 2, 3, Tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 [TIE2]), stem cell growth factor receptor (KIT, rearranged during transfection [RET], p38-alpha, a member of the mitogen activated protein kinase [MAPK] family, proto-oncogene c-RAF [c-RAF], proto-oncogene BRAF [BRAF], BRAFV600E), metastasis (VEGFR3, platelet-derived growth factor receptor [PDGFR], fibroblast growth factor receptor1 [FGFR1]) and tumor immunity (colony stimulating factor 1 receptor [CSF1R]). | Drug | A, B |
Primary outcome
Overall Survival
Time frame: 24 months
The primary objective is to evaluate whether, or not, an 80 mg/day starting dose of regorafenib that escalates weekly by 40 mg until 160 mg/day is non-inferior compared to the FDA approved labeling 160 mg starting dose of regorafenib in terms of Overall Survival in HCC subjects.
6 secondary outcomes
Regorafenib treatment cycles
Time frame: 24 months
Tumor Progression
Time frame: 24 months
Dosing Patterns
Time frame: 24 months
EORTC QOL-C30 Quality of Life Measurements
Time frame: 24 months
Optional CD14-16 cell sub-study
Time frame: 36 months
FACIT FACT-Hep Quality of Life Measurements
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Enrollment rate not sufficient to meet funding entity's corporation timeline expectations, entity terminated study's fiscal support. Termination decision was purely administrative in nature and did not involve drug or patient safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No. Only aggregated data will be available for review, analysis and reporting.
Related trials for Hepatocellular Carcinoma
Recruiting
Improving Hepatocellular Carcinoma Screening
Magnetic Resonance Imaging, Hepatocellular Carcinoma
RecruitingObservational study
DNP-MRSI of HCC Metabolism to Predict Therapeutic Response
Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC, Hepatocellular Carcinoma (HCC)
Recruiting
Targeted Navigation in Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma, Cholangiocarcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine T Frenette, MD principal investigator
Scripps MD Anderson Cancer Center
Madappa Kundranda, MD principal investigator
Banner MD Andersen Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regorafenib 40 MG in people with Hepatocellular Carcinoma, run by SC Liver Research Consortium, LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment rate not sufficient to meet funding entity's corporation timeline expectations, entity terminated study's fiscal support. Termination decision was purely administrative in nature and did not involve drug or patient safety issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.