Hepatocellular Carcinoma (HCC)Phase 2REVIVENCT07495579
Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE)
A Phase 2 study testing Lenvatinib and regorafenib in people with Hepatocellular Carcinoma (HCC), run by Asan Medical Center at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn if lenvatinib or regorafenib can help treat people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed with surgery after first treatment with immunotherapy-based drug combinations. It will also look at the safety of these treatments. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Lenvatinib and regorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older
- Diagnosis of hepatocellular carcinoma according to the American Association for the Study of Liver Diseases (AASLD) guidelines
- Unresectable or metastatic hepatocellular carcinoma not amenable to curative treatments such as surgical resection, liver transplantation, or local ablation
- Prior first-line systemic treatment with an immune checkpoint inhibitor-based combination regimen, defined as dual immune checkpoint inhibitor therapy (e.g., nivolumab plus ipilimumab or durvalumab plus tremelimumab) for the REVIVE-1 cohort, and immune checkpoint inhibitor-based combination therapy (e.g., atezolizumab plus bevacizumab, durvalumab plus tremelimumab, nivolumab plus ipilimumab, camrelizumab plus rivoceranib, or similar regimens) for the REVIVE-2 cohort; prior participation in clinical trials using these regimens is allowed
- Radiologic disease progression after at least 2 cycles of first-line treatment
- At least one measurable lesion according to RECIST v1.1
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- Recovery from toxicities related to prior therapy to grade 1 or lower, except for clinically stable or non-clinically significant toxicities
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Absolute neutrophil count ≥ 1.0 × 10⁹/L
- Platelet count ≥ 75 × 10⁹/L for REVIVE-1 or ≥ 50 × 10⁹/L for REVIVE-2
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL/min
- Proteinuria <3 g in 24-hour urine collection or urine protein-to-creatinine ratio <3 mg/mg
- Child-Pugh A (score 5-6) for REVIVE-1 cohort or Child-Pugh B (score 7-8) for REVIVE-2 cohort
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)
- Patients with chronic hepatitis B infection receiving appropriate antiviral therapy if HBV DNA positive
- QTcF ≤ 480 ms on electrocardiogram obtained within 21 days prior to enrollment
- Ability to understand and willingness to sign written informed consent
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after the last dose
Who cannot join
- Known fibrolamellar hepatocellular carcinoma or mixed hepatocellular-cholangiocarcinoma
- Prior treatment with lenvatinib or regorafenib
- Receipt of two or more prior systemic treatment regimens for advanced hepatocellular carcinoma
- Known brain metastases or epidural disease unless adequately treated and clinically stable for at least 3 months
- Congestive heart failure greater than New York Heart Association class II
- Unstable angina, myocardial infarction, or stroke within 6 months
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- Clinically significant cardiac arrhythmia requiring treatment
- Uncontrolled hypertension despite optimal medical therapy (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg)
- Active bleeding disorders or high risk of severe bleeding
- Tumor invasion of major blood vessels with high risk of bleeding
- Gastrointestinal conditions with high risk of perforation or fistula, including active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis, or recent gastrointestinal perforation
- Major surgery within 2 months before enrollment or incomplete recovery from surgery
- Moderate to severe ascites
- Known hypersensitivity to study drugs or their components
- Pregnancy or breastfeeding
- Diagnosis of another active malignancy requiring treatment within the past 2 years, except for adequately treated low-risk cancers
- Uncorrected electrolyte abnormalities
- Any medical condition that, in the investigator's judgment, would make the participant unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Asan Medical Center
Seoul, 05505
Changhoon Yoo, 82-2-3010-1727, cyoo.amc@gmail.com
About this study
Official title: A Multicenter Phase 2 Study of Lenvatinib or Regorafenib in Patients With Unresectable or Metastatic Hepatocellular Carcinoma Who Progressed After First-Line Immunotherapy-Based Combination Therapy (REVIVE)
The goal of this clinical trial is to learn if lenvatinib or regorafenib can help treat people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed with surgery after first treatment with immunotherapy-based drug combinations. It will also look at the safety of these treatments.
The main questions this study aims to answer are:
Read more
- How long lenvatinib can delay cancer growth in people with good liver function (Child-Pugh)A after dual immunotherapy
- How long people with reduced liver function (Child-Pugh B7-B8) live after treatment with lenvatinib or regorafenib after first-line immunotherapy-based combination treatment
- What side effects people experience during treatment
- How many people have their tumors shrink or disappear
The study has two parts:
In REVIVE-1, participants with Child-Pugh A liver function will receive lenvatinib.
In REVIVE-2, participants with Child-Pugh B7 to B8 liver function will receive either lenvatinib or regorafenib.
Participants will:
- take lenvatinib or regorafenib by mouth
- visit the clinic regularly for physical exams, blood and urine tests, and safety checks
- have computed tomography (CT) scans every 8 weeks to check their cancer
- be followed during and after treatment to assess outcomes and side effects
Read the detailed description
Hepatocellular carcinoma (HCC) is a leading cause of cancer-related death worldwide. Immune checkpoint inhibitor (ICI)-based combination therapies have become standard first-line treatments for patients with unresectable or metastatic HCC. Several clinical trials have demonstrated survival benefits with these regimens, including atezolizumab plus bevacizumab (IMbrave150), durvalumab plus tremelimumab (HIMALAYA), and nivolumab plus ipilimumab (CheckMate 9DW). As a result, immunotherapy-based combinations are widely used as first-line systemic treatment for advanced HCC.
Despite these advances, most patients eventually experience disease progression and require subsequent systemic therapy. However, prospective evidence regarding optimal second-line treatment after progression on ICI-based therapy remains limited. Multikinase inhibitors such as sorafenib, lenvatinib, and regorafenib were originally approved based on studies conducted before the widespread use of immunotherapy. Therefore, their role after failure of modern ICI-based regimens remains unclear.
In addition, most clinical trials in advanced HCC have primarily enrolled patients with preserved liver function (Child-Pugh A). Evidence for patients with Child-Pugh B liver function is limited, and prospective studies evaluating systemic therapies in this population are scarce.
The REVIVE study is a multicenter phase 2 clinical trial designed to evaluate the efficacy and safety of lenvatinib or regorafenib in patients with unresectable or metastatic hepatocellular carcinoma who have progressed after first-line immunotherapy-based combination therapy.
The study consists of two cohorts.
REVIVE-1 is a prospective, multicenter, single-arm phase 2 cohort evaluating lenvatinib in participants with Child-Pugh A liver function whose disease has progressed after first-line dual immune checkpoint inhibitor therapy.
REVIVE-2 is a multicenter, randomized, non-comparative phase 2 cohort evaluating lenvatinib or regorafenib in participants with Child-Pugh B7 to B8 liver function whose disease has progressed after first-line immunotherapy-based combination therapy.
This study aims to generate prospective evidence regarding the efficacy and safety of lenvatinib and regorafenib as second-line treatments after failure of immunotherapy-based therapy in advanced hepatocellular carcinoma, , particularly in settings where evidence remains limited, such as after dual ICI therapy and in patients with Child-Pugh B liver function.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Lenvatinib, regorafenib
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, Regorafenib, Second-line Therapy, Dual Immune Checkpoint Inhibitor, Child-Pugh B
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Lenvatinib is an oral multikinase inhibitor targeting vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), platelet-derived growth factor receptor alpha (PDGFR-α), RET, and KIT. In this study, lenvatinib is administered orally as second-line treatment according to protocol-defined dosing based on liver function and body weight.
regorafenibDrug
Regorafenib is an oral multikinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases including VEGFR, FGFR, PDGFR, KIT, RET, and RAF kinases. In this study, regorafenib is administered orally as second-line treatment according to protocol-defined dosing.
| Study group | Role | What they receive |
|---|---|---|
| REVIVE-1: Lenvatinib | Experimental | Lenvatinib orally once daily at a dose based on body weight (12 mg for ≥60 kg or 8 mg for <60 kg) Receives: Drug: Lenvatinib |
| REVIVE-2: Lenvatinib | Experimental | Lenvatinib orally once daily at a starting dose of 4 mg or 8 mg based on body weight, with step-up to 8 mg or 12 mg after 2 weeks if tolerated Receives: Drug: Lenvatinib |
| REVIVE-2: Regorafenib | Experimental | Regorafenib administered orally at a starting dose of 80 mg once daily for 3 weeks followed by 1 week off in each 4-week cycle, with step-up to 120 mg after 2 weeks if tolerated. Receives: Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) in REVIVE-1
Progression-free survival is defined as the time from first dose of study treatment to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first, in the REVIVE-1 cohort.
Measured: Up to 24 months
Overall Survival (OS) in REVIVE-2
Overall survival is defined as the time from first dose of study treatment to death from any cause in the REVIVE-2 cohort.
Measured: Up to 30 months
Secondary outcomes (5)
Overall Survival (OS) in REVIVE-1
Overall survival is defined as the time from first dose of study treatment to death from any cause in the REVIVE-1 cohort.
Measured: Up to 24 months
Progression-Free Survival (PFS) in REVIVE-2
Progression-free survival is defined as the time from first dose of study treatment (lenvatinib or regorafenib) to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first, in the REVIVE-2 cohort.
Measured: Up to 30 months
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve a confirmed complete response or partial response according to RECIST v1.1. in both REVIVE-1 and REVIVE-2 cohorts.
Measured: Up to 24 months
Incidence of Treatment-Emergent Adverse Events
The incidence and severity of treatment-emergent adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in both REVIVE-1 and REVIVE-2 cohorts.
Measured: Up to 30 months
Time to Liver Function Deterioration in REVIVE-2
Time to liver function deterioration is defined as the time from first dose of study treatment to worsening of liver function, such as progression from Child-Pugh B7 to B8-9 or C, from Child-Pugh B8 to B9 or C, or worsening of albumin-bilirubin (ALBI) grade from 2 to 3.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- This study includes two cohorts. REVIVE-1 is a single-arm phase 2 cohort evaluating lenvatinib in participants with Child-Pugh A liver function after progression on dual immune checkpoint inhibitor therapy. REVIVE-2 is a randomized, non-comparative phase 2 cohort evaluating lenvatinib or regorafenib in participants with Child-Pugh B7-8 liver function after progression on immunotherapy-based combination therapy.
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Cancer Study Group, Boryung Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Changhoon Yoo, Asan Medical Center
- Investigators
- Changhoon Yoo, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495579
- Sponsor's protocol ID
- KCSG HB25-15
- Other IDs
- HB25-15
- Acronym
- REVIVE
- Status last verified
- May 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2 Study of Lenvatinib or Regorafenib in Patients With Unresectable or Metastatic Hepatocellular Carcinoma Who Progressed After First-Line Immunotherapy-Based Combination Therapy (REVIVE)
- ClinicalTrials.gov ID
- NCT07495579
- Acronym / sponsor ID
- REVIVE / KCSG HB25-15
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, Lenvatinib, Regorafenib, Second-line Therapy, Dual Immune Checkpoint Inhibitor, Child-Pugh B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korean Cancer Study Group, Boryung Pharmaceutical Co., Ltd
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (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.
The goal of this clinical trial is to learn if lenvatinib or regorafenib can help treat people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed with surgery after first treatment with immunotherapy-based drug combinations. It will also look at the safety of these treatments.
The main questions this study aims to answer are:
- How long lenvatinib can delay cancer growth in people with good liver function (Child-Pugh)A after dual immunotherapy
- How long people with reduced liver function (Child-Pugh B7-B8) live after treatment with lenvatinib or regorafenib after first-line immunotherapy-based combination treatment
- What side effects people experience during treatment
- How many people have their tumors shrink or disappear
The study has two parts:
In REVIVE-1, participants with Child-Pugh A liver function will receive lenvatinib.
In REVIVE-2, participants with Child-Pugh B7 to B8 liver function will receive either lenvatinib or regorafenib.
Participants will:
- take lenvatinib or regorafenib by mouth
- visit the clinic regularly for physical exams, blood and urine tests, and safety checks
- have computed tomography (CT) scans every 8 weeks to check their cancer
- be followed during and after treatment to assess outcomes and side effects
Detailed description
Hepatocellular carcinoma (HCC) is a leading cause of cancer-related death worldwide. Immune checkpoint inhibitor (ICI)-based combination therapies have become standard first-line treatments for patients with unresectable or metastatic HCC. Several clinical trials have demonstrated survival benefits with these regimens, including atezolizumab plus bevacizumab (IMbrave150), durvalumab plus tremelimumab (HIMALAYA), and nivolumab plus ipilimumab (CheckMate 9DW). As a result, immunotherapy-based combinations are widely used as first-line systemic treatment for advanced HCC.
Despite these advances, most patients eventually experience disease progression and require subsequent systemic therapy. However, prospective evidence regarding optimal second-line treatment after progression on ICI-based therapy remains limited. Multikinase inhibitors such as sorafenib, lenvatinib, and regorafenib were originally approved based on studies conducted before the widespread use of immunotherapy. Therefore, their role after failure of modern ICI-based regimens remains unclear.
In addition, most clinical trials in advanced HCC have primarily enrolled patients with preserved liver function (Child-Pugh A). Evidence for patients with Child-Pugh B liver function is limited, and prospective studies evaluating systemic therapies in this population are scarce.
The REVIVE study is a multicenter phase 2 clinical trial designed to evaluate the efficacy and safety of lenvatinib or regorafenib in patients with unresectable or metastatic hepatocellular carcinoma who have progressed after first-line immunotherapy-based combination therapy.
The study consists of two cohorts.
REVIVE-1 is a prospective, multicenter, single-arm phase 2 cohort evaluating lenvatinib in participants with Child-Pugh A liver function whose disease has progressed after first-line dual immune checkpoint inhibitor therapy.
REVIVE-2 is a multicenter, randomized, non-comparative phase 2 cohort evaluating lenvatinib or regorafenib in participants with Child-Pugh B7 to B8 liver function whose disease has progressed after first-line immunotherapy-based combination therapy.
This study aims to generate prospective evidence regarding the efficacy and safety of lenvatinib and regorafenib as second-line treatments after failure of immunotherapy-based therapy in advanced hepatocellular carcinoma, , particularly in settings where evidence remains limited, such as after dual ICI therapy and in patients with Child-Pugh B liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study includes two cohorts. REVIVE-1 is a single-arm phase 2 cohort evaluating lenvatinib in participants with Child-Pugh A liver function after progression on dual immune checkpoint inhibitor therapy. REVIVE-2 is a randomized, non-comparative phase 2 cohort evaluating lenvatinib or regorafenib in participants with Child-Pugh B7-8 liver function after progression on immunotherapy-based combination therapy.
| Arm | Type | Receives |
|---|---|---|
| REVIVE-1: Lenvatinib | Experimental | Drug: LenvatinibLenvatinib orally once daily at a dose based on body weight (12 mg for ≥60 kg or 8 mg for <60 kg) |
| REVIVE-2: Lenvatinib | Experimental | Drug: LenvatinibLenvatinib orally once daily at a starting dose of 4 mg or 8 mg based on body weight, with step-up to 8 mg or 12 mg after 2 weeks if tolerated |
| REVIVE-2: Regorafenib | Experimental | Drug: regorafenibRegorafenib administered orally at a starting dose of 80 mg once daily for 3 weeks followed by 1 week off in each 4-week cycle, with step-up to 120 mg after 2 weeks if tolerated. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age 19 years or older
- Diagnosis of hepatocellular carcinoma according to the American Association for the Study of Liver Diseases (AASLD) guidelines
- Unresectable or metastatic hepatocellular carcinoma not amenable to curative treatments such as surgical resection, liver transplantation, or local ablation
- Prior first-line systemic treatment with an immune checkpoint inhibitor-based combination regimen, defined as dual immune checkpoint inhibitor therapy (e.g., nivolumab plus ipilimumab or durvalumab plus tremelimumab) for the REVIVE-1 cohort, and immune checkpoint inhibitor-based combination therapy (e.g., atezolizumab plus bevacizumab, durvalumab plus tremelimumab, nivolumab plus ipilimumab, camrelizumab plus rivoceranib, or similar regimens) for the REVIVE-2 cohort; prior participation in clinical trials using these regimens is allowed
- Radiologic disease progression after at least 2 cycles of first-line treatment
Key exclusion criteria (18 listed)
- Known fibrolamellar hepatocellular carcinoma or mixed hepatocellular-cholangiocarcinoma
- Prior treatment with lenvatinib or regorafenib
- Receipt of two or more prior systemic treatment regimens for advanced hepatocellular carcinoma
- Known brain metastases or epidural disease unless adequately treated and clinically stable for at least 3 months
- Congestive heart failure greater than New York Heart Association class II
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 |
|---|---|---|
| LenvatinibLenvatinib is an oral multikinase inhibitor targeting vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), platelet-derived growth factor receptor alpha (PDGFR-α), RET, and KIT. In this study, lenvatinib is administered orally as second-line treatment according to protocol-defined dosing based on liver function and body weight. | Drug | REVIVE-1: Lenvatinib, REVIVE-2: Lenvatinib |
| regorafenibRegorafenib is an oral multikinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases including VEGFR, FGFR, PDGFR, KIT, RET, and RAF kinases. In this study, regorafenib is administered orally as second-line treatment according to protocol-defined dosing. | Drug | REVIVE-2: Regorafenib |
Primary outcome
Progression-Free Survival (PFS) in REVIVE-1
Time frame: Up to 24 months
Progression-free survival is defined as the time from first dose of study treatment to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first, in the REVIVE-1 cohort.
Overall Survival (OS) in REVIVE-2
Time frame: Up to 30 months
Overall survival is defined as the time from first dose of study treatment to death from any cause in the REVIVE-2 cohort.
5 secondary outcomes
Overall Survival (OS) in REVIVE-1
Time frame: Up to 24 months
Progression-Free Survival (PFS) in REVIVE-2
Time frame: Up to 30 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 30 months
Time to Liver Function Deterioration in REVIVE-2
Time frame: Up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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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.
Changhoon Yoo principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib and regorafenib in people with Hepatocellular Carcinoma (HCC), run by Asan Medical Center at 1 site in South Korea.
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 18 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changhoon Yoo (82-2-3010-1727, cyoo.amc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) in REVIVE-1 (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 27 May 2026.