Hepatocellular Carcinoma, Unresectable, AdvancedPhase 2PEACHNCT05517239
Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment
A Phase 2 study testing Gemcitabine, Oxaliplatin in people with Hepatocellular Carcinoma, Unresectable, Advanced, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to test the safety of gemcitabine and oxaliplatin regimen and to see its effects on sorafenib treatment failed hepatocellular carcinoma patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Unresectable, Advanced
- What is being tested?
- Gemcitabine, Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2015to 30 Sep 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who signed informed consent.
- Male or female ≥ 20 years of age.
- Diagnosis of advanced HCC according to the AASLD.
- Unresectable HCC
- Advanced disease defined as extrahepatic metastasis or locally advanced disease not amenable to surgical resection or other local-regional therapies including transhepatic arterial (chemo) embolization (TACE or TAE) and local ablative therapy
- Patient who progressed after prior local-regional therapy (local-regional therapy must be completed at least 4weeks prior to the baseline).
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- Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted.
- Documented radiological confirmation of disease progression during or after sorafenib treatment
- Intolerance to sorafenib is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation
- Patients must have a life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance state ≤ 2
- Measurable lesion according to the RECIST 1.1 criteria
- Child Pugh Class A or B7
- Patients must have adequate organ and marrow function:
- Absolute neutrophil count (ANC) ≥1.5X10^9/L
- Platelets≥75X10^9/L
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) < 5 Upper Normal Limit(UNL)
- Total Bilirubin≤1.5 X UNL
- Controlled brain metastasis is allowed(except brain metastasis to require treatment to control symptom-wash out of treatment for brain metastasis is not required.)
Who cannot join
- Imaging findings for HCC corresponding to any of the following
- HCC with >60% liver occupation
- Portal vein invasion at the main portal branch (Vp4)
- History of a secondary malignancy within 3 years
- in situ cervical cancer, adequately treated basal cell or superficial bladder cancer
- History of chemotherapy or radiotherapy within 4 weeks
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- but, 2 weeks for sorafenib and radiotherapy site of bone lesion
- Patient who not recovered toxicity ≥ grade 2 related prior local-regional therapy or systemic therapy.
- Patients with any known severe allergy to Gemcitabine or platinum compound.
- Active gastro-Intestinal bleeding.
- Patients who are receiving any other chemotherapy or study treatments.
- Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
- Patients with active infections requiring an IV antibiotic.
- Neuropathy ≥ grade 2
- Patients with known interstitial lung disease or pulmonary fibrosis.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Phase II Study of Gemcitabine With Oxaliplatin in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment
The purpose of this study is to test the safety of gemcitabine and oxaliplatin regimen and to see its effects on sorafenib treatment failed hepatocellular carcinoma patients.
Read the detailed description
Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted. Treatment is given in cycles, each cycle is 2 weeks long. Tumor measurements by CT and/or MRI will be repeated every 3 cycles. Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.
- Being tested
- Gemcitabine, Oxaliplatin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, OxaliplatinDrug
Also called Gemzar, Eloxatin
Gemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Oxaliplatin | Experimental | Gemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death. Receives: Drug: Gemcitabine, Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Measured: 1 year
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall safety profile verified as relevance of adverse events and laboratory abnormality based on CTCAE v4.0.
Measured: From enrollment to 30 days follow-up after the end of treatment
Response rate
Assessed by RECIST 1.1
Measured: from enrollment to 1 year follow-up after the end of treatment
Overall survival
Estimated by the Kaplan-Meier method
Measured: From enrollment to 1 year follow-up after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 May 2015
- Primary completion30 Sep 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma, Unresectable, AdvancedStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hye Jin Choi, Principal investigator, Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517239
- Sponsor's protocol ID
- 4-2014-0269
- Acronym
- PEACH
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine With Oxaliplatin in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment
- ClinicalTrials.gov ID
- NCT05517239
- Acronym / sponsor ID
- PEACH / 4-2014-0269
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 26 Aug 2022 (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 purpose of this study is to test the safety of gemcitabine and oxaliplatin regimen and to see its effects on sorafenib treatment failed hepatocellular carcinoma patients.
Detailed description
Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted. Treatment is given in cycles, each cycle is 2 weeks long. Tumor measurements by CT and/or MRI will be repeated every 3 cycles. Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Oxaliplatin | Experimental | Drug: Gemcitabine, OxaliplatinGemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient who signed informed consent.
- Male or female ≥ 20 years of age.
- Diagnosis of advanced HCC according to the AASLD.
- Unresectable HCC
- Advanced disease defined as extrahepatic metastasis or locally advanced disease not amenable to surgical resection or other local-regional therapies including transhepatic arterial (chemo) embolization (TACE or TAE) and local ablative therapy
Key exclusion criteria (15 listed)
- Imaging findings for HCC corresponding to any of the following
- History of a secondary malignancy within 3 years
- History of chemotherapy or radiotherapy within 4 weeks
- Patient who not recovered toxicity ≥ grade 2 related prior local-regional therapy or systemic therapy.
- Patients with any known severe allergy to Gemcitabine or platinum compound.
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 |
|---|---|---|
| Gemcitabine, OxaliplatinAlso: Gemzar, EloxatinGemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death. | Drug | Gemcitabine, Oxaliplatin |
Primary outcome
Progression free survival
Time frame: 1 year
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From enrollment to 30 days follow-up after the end of treatment
Response rate
Time frame: from enrollment to 1 year follow-up after the end of treatment
Overall survival
Time frame: From enrollment to 1 year follow-up after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- 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. This study is not recruiting at the moment.
Hye Jin Choi principal investigator
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
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 Gemcitabine, Oxaliplatin in people with Hepatocellular Carcinoma, Unresectable, Advanced, run by Yonsei University 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 19 inclusion and 15 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: finished, as of the sponsor's last update on 26 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (time frame: 1 year). 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 26 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.