Hepatocellular CarcinomaNCT01328223
Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by China Medical University Hospital at 3 sites in Taiwan.
Trial summary
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… 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?
- sorafenib and radiotherapy for hepatocellular carcinoma
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 3 sitesTaiwan
- Study dates
- Sep 2010to Dec 2012
- 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: Paitents with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE.
Who may be able to join
- Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TACE. A maximal tumor diameter > 3.0 cm.
- 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 ≧ 50,000/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 enrollment.
- 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites, 3 recruiting
- Recruiting
Shang-Wen Chen
Taichung, Taiwan, 404
Shang-Wen Chen, MD, 886-4-22052121 ext. 7450, vincent1680616@yahoo.com.tw
Yu-Cheng Kuo
- Recruiting
Li-Ching Lin
Tainan, Taiwan, 700
Li-Ching Lin, MD, liching51@yahoo.com.tw
- Recruiting
Jeng-Fong Chiou
Taipei, Taiwan, 100
Jeng-Fong Chiou, MD;PhD, sjfchiou@xuite.net
About this study
Official title: Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
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, the investigators 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.
Read the detailed description
The primary end points are response rate and toxicities profile. The secondary endpoints are time to disease-free survival, overall survival, and quality of life assessment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- sorafenib and radiotherapy for hepatocellular carcinoma
- Keywords
- Hepatocellular carcinoma, radiotherapy, sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenib and radiotherapy for hepatocellular carcinomaRadiation
Also called Combined radiotherapy and sorafenib.
Concurrent and maintenance sorafenib 400mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy efficacy | 1. Concurrent stage with RT: sorafenib 400mg twice daily
2. Maintenance stage after RT: sorafenib 400mg twice daily Treatment can be continued until the occurrence of clinical or radiologic progression, the occurrence of either unacceptable adverse events, death, or any criteria met for removal from the protocol treatment. Basically, minimum maintenance duration of 6 months is recommended, not mandatory. Receives: Radiation: sorafenib and radiotherapy for hepatocellular carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
- The tumor response rate will be evaluated at the 6th month after the ending of radiotherapy.
- The response rate includes complete and partial response according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Measured: 6 months
Secondary outcomes (2)
Disease progression-free survival
Disease progression-free survival:
Patients with the evidence of clinical or radiographic progressive disease will be defined as disease progression. The average time period for the follow-up will be two years.
Measured: 2 years
Overall survival
Participants will be followed. The average time period will be two years.
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 posted4 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (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
- NCT01328223
- Sponsor's protocol ID
- Radiotherapy-Sorafenib
- Status last verified
- Mar 2011
- First submitted
- 20 Mar 2011
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01328223
- Acronym / sponsor ID
- Radiotherapy-Sorafenib
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, radiotherapy, sorafenib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Apr 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.
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, the investigators 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.
Detailed description
The primary end points are response rate and toxicities profile. The secondary endpoints are time to disease-free survival, overall survival, and quality of life assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy efficacy | – | Radiation: sorafenib and radiotherapy for hepatocellular carcinoma1. Concurrent stage with RT: sorafenib 400mg twice daily 2. Maintenance stage after RT: sorafenib 400mg twice daily Treatment can be continued until the occurrence of clinical or radiologic progression, the occurrence of either unacceptable adverse events, death, or any criteria met for removal from the protocol treatment. Basically, minimum maintenance duration of 6 months is recommended, not mandatory. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitents with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE.
Key inclusion criteria (19 listed)
- Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TACE. A maximal tumor diameter > 3.0 cm.
- 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 (14 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 |
|---|---|---|
| sorafenib and radiotherapy for hepatocellular carcinomaAlso: Combined radiotherapy and sorafenib.Concurrent and maintenance sorafenib 400mg twice daily | Radiation | radiotherapy efficacy |
Primary outcome
Response rate
Time frame: 6 months
1. The tumor response rate will be evaluated at the 6th month after the ending of radiotherapy. 2. The response rate includes complete and partial response according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
2 secondary outcomes
Disease progression-free survival
Time frame: 2 years
Overall survival
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 4 Apr 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
3 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 3 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 19 inclusion and 14 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 4 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 (886-4-2205212 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: 6 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 4 Apr 2011.