Hepatocellular CarcinomaNCT01319942
Combined Radiotherapy and Sorafenib in Patients With Hepatoma
An observational study of Hepatocellular Carcinoma, run by China Medical University Hospital at 2 sites in Taiwan.
Trial summary
This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with locally advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Radiotherapy combined with sorafenib
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jun 2010to Jun 2013
- Phase
- Observational
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 45 patients withunresectable hepatoma
Who may be able to join
- Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TAE.
- Age: 20 ~ 69 years.
- ECOG 0 or 1.
- Life expectancy of at least 12 weeks.
- Child-Pugh A or B (preferentially score ≦ 7).
- Cancer of the Liver Italian Program (CLIP) score ≦ 3.
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- Pretreatment liver function test and renal function test:
- Total bilirubin < 1.5 times the upper limit of normal (ULN)≦ 3.0(ULN)in patients treated by biliary drainage for obstructive jaundice.
- GOP/GPT ≦ 5 X of upper limit of normal range.
- Alkaline phosphatase ≦ 4X of upper limit of normal range.
- Prothrombin time/partial prothrombin time < 1.5 X of ULN.
- Serum Creatinine ≦ 1.0 x ULN.
- Pretreatment blood count:
- Hemoglobulin ≧ 9 g/dl.
- Absolute neutrophil count ≧ 1500/mm3.
- Platelet count ≧ 100,000/mm3.
- Subjects with at least one uni-dimensional or bi-dimensional measurable lesion. Lesion must be measured by CT scan or MRI.
- Patients must fully recover from prior therapy that given > 4 weeks before enrolment.11. Signed informed consent must be obtained prior to any study related procedures.
Who cannot join
- Child-Pugh C
- CLIP score ≧ 4
- Patients with evidence of extrahepatic or metastatic disease
- Patients with evidence of massive ascites
- Patients receiving previous irradiation to liver
- Patients with previous use of Thalidomide less than 6 months from entering of the study
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- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted)
- Active clinically serious infections ( > grade 2 CTC version 2)
- Patients undergoing renal dialysis
- Patients with evidence or history of bleeding diathesis
- Prior treatment with EGFR TKIs or VEGFR TKIs
- Hypertension uncontrolled by medical therapy
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper.
- Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin and suramin)
- Major surgery within 4 weeks of start of study
- Concomitant treatment with strong CYP3A4 inducers or inhibitors
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.
- Pregnant or breast-feeding patients
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- Patients with seizure disorder requiring medication
- History of organ allograft
- Use of biologic response modifiers, such as G-CSF, within 3 week of study entry
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Patients unable to swallow oral medications
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Chi-Mei Hospital
Tainan, Taiwan, 600
Li-Ching Lin, MD, 886-6-2812811 ext. 53501, liching51@yahoo.com.tw
Li-Ching Lin, MD
- Recruiting
Taipei Medical University Hospital
Taipei, Taiwan, 100
Jeng-Fong Chiou, MD;PhD, 886-2-27372181 ext. 2130, sjfchiou@xuite.net
Jen-Fong Chiou, MD;PhD
About this study
This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with locally advanced hepatocellular carcinoma.
Read the detailed description
Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. With the development of new radiotherapy (RT) technique, RT can be more safely given to patients with larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC. Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70 %. However, it has not been definitively shown to prolong the overall or disease-free survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical investigation with molecular study suggests that sublethal dose of RT promoted HCC growth outside RT field.
Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis inhibitors seem to be synergistic with irradiation when using before RT, concurrently with RT, or after RT. Thus, we design a single-arm phase II clinical trial to investigate the efficacy of combined RT with sorafenib.
The eligibility criteria are patients with unresectable HCC; good performance status; no prior radiotherapy for the liver; clinical measurable tumor; good liver function and good compliance. After entering this study, the testee will receive RT to hepatic tumor with concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued until the occurrence of clinical or radiologic progression, or the occurrence of either unacceptable adverse events or death. Minimum maintenance duration of 6 months is recommended, but not mandatory. The primary end points are response rate and toxicities profile. The secondary endpoints are time to radiological progression interval (TRPI), overall survival, and quality of life assessment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radiotherapy combined with sorafenib
- Keywords
- Radiotherapy, Sorafenib, Treatment outcome
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy combined with sorafenibOther
Also called Radiotherapy with sorafenib
Radiotherapy: 46 Gy to 60 Gy prescribed to involved hepatic tumor Sorafenib: 2 tablet of sorafenib (200mg) twice daily (totally 800mg per day)
| Study group | Role | What they receive |
|---|---|---|
| Unresectable hepatoma | Unresectable hepatoma, unsuitable for transarterial embolization or local failure after transarterial embolization Receives: Other: Radiotherapy combined with sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
- Response rate at 1-month and 6-month after radiotherapy.
- Toxicities profile of combinede treatment
Measured: 1-month and 6-month response rate
Secondary outcomes (1)
Time-to radiological progression interval
- Time-to radiological progression interval
- 2-year overall survival
- 2-year progression-free survival
- Quality of life
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
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.
- More trials run by China Medical University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shang-Wen Chen, MD, Principal investigator, Department of Radiation Oncology, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319942
- Sponsor's protocol ID
- RT-sorafenib
- Status last verified
- Mar 2011
- First submitted
- 20 Jul 2010
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Radiotherapy and Sorafenib in Patients With Hepatoma
- ClinicalTrials.gov ID
- NCT01319942
- Acronym / sponsor ID
- RT-sorafenib
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Radiotherapy, Sorafenib, Treatment outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 22 Mar 2011 (estimated)
- 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 study aims to test the efficacy of combined radiotherapy and sorafenib in patients with locally advanced hepatocellular carcinoma.
Detailed description
Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. With the development of new radiotherapy (RT) technique, RT can be more safely given to patients with larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC. Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70 %. However, it has not been definitively shown to prolong the overall or disease-free survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical investigation with molecular study suggests that sublethal dose of RT promoted HCC growth outside RT field.
Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis inhibitors seem to be synergistic with irradiation when using before RT, concurrently with RT, or after RT. Thus, we design a single-arm phase II clinical trial to investigate the efficacy of combined RT with sorafenib.
The eligibility criteria are patients with unresectable HCC; good performance status; no prior radiotherapy for the liver; clinical measurable tumor; good liver function and good compliance. After entering this study, the testee will receive RT to hepatic tumor with concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued until the occurrence of clinical or radiologic progression, or the occurrence of either unacceptable adverse events or death. Minimum maintenance duration of 6 months is recommended, but not mandatory. The primary end points are response rate and toxicities profile. The secondary endpoints are time to radiological progression interval (TRPI), overall survival, and quality of life assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable hepatoma | – | Other: Radiotherapy combined with sorafenibUnresectable hepatoma, unsuitable for transarterial embolization or local failure after transarterial embolization |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45 patients withunresectable hepatoma
Key inclusion criteria (18 listed)
- Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TAE.
- Age: 20 ~ 69 years.
- ECOG 0 or 1.
- Life expectancy of at least 12 weeks.
- Child-Pugh A or B (preferentially score ≦ 7).
Key exclusion criteria (29 listed)
- Child-Pugh C
- CLIP score ≧ 4
- Patients with evidence of extrahepatic or metastatic disease
- Patients with evidence of massive ascites
- Patients receiving previous irradiation to liver
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 |
|---|---|---|
| Radiotherapy combined with sorafenibAlso: Radiotherapy with sorafenibRadiotherapy: 46 Gy to 60 Gy prescribed to involved hepatic tumor Sorafenib: 2 tablet of sorafenib (200mg) twice daily (totally 800mg per day) | Other | Unresectable hepatoma |
Primary outcome
Response rate
Time frame: 1-month and 6-month response rate
1. Response rate at 1-month and 6-month after radiotherapy. 2. Toxicities profile of combinede treatment
1 secondary outcome
Time-to radiological progression interval
Time frame: 2-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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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.
Shang-Wen Chen, MD principal investigator
Department of Radiation Oncology, China Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by China Medical University Hospital at 2 sites in Taiwan.
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 18 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shang-Wen Chen, MD (886-4-22052121 ext. 7450, vincent1680616@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 1-month and 6-month response rate). 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 22 Mar 2011.