Intrahepatic CholangiocarcinomaNCT02588755
TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection
A study testing TACE+Tegafur and TACE in people with Intrahepatic Cholangiocarcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- TACE+Tegafur and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients > 18 years and <=70 years of age.
- Pathological evidence of ICC
- Tumors can be completely resected.
- Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- Patients who can understand this trial and have signed information consent.
Who cannot join
- Tumors can not be resected .
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
- Patients with a medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Liver function:Child C.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Shen Feng, MD, 0086-021-25070805, shenfengdfgd@yahoo.com.cn
Yong Xia, Doctor, 86-021-81875495
About this study
Official title: Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- TACE+Tegafur, TACE
- Keywords
- Chemoembolization, Therapeutic, Tegafur
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE+TegafurProcedure or surgery
Also called TACE followed by Tegafur
Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.
TACEProcedure or surgery
TACE alone
| Study group | Role | What they receive |
|---|---|---|
| TACE+ Tegafur | Active comparator | Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection. Receives: Procedure: TACE+Tegafur |
| TACE | Experimental | Patients will be treated with TACE alone in 4 or 8 weeks after resection. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rates of each group
Measured: 3 years
Secondary outcomes (1)
Occurrence rate of recurrence of each group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588755
- Sponsor's protocol ID
- EHBHKY2015-0123
- Status last verified
- Mar 2016
- First submitted
- 27 Oct 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02588755
- Acronym / sponsor ID
- EHBHKY2015-0123
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Chemoembolization, Therapeutic, Tegafur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Oct 2015 (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.
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+ Tegafur | Active comparator | Procedure: TACE+TegafurPatients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection. |
| TACE | Experimental | Procedure: TACEPatients will be treated with TACE alone in 4 or 8 weeks after resection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients > 18 years and <=70 years of age.
- Pathological evidence of ICC
- Tumors can be completely resected.
- Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- Patients who can understand this trial and have signed information consent.
Key exclusion criteria (5 listed)
- Tumors can not be resected .
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
- Patients with a medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Liver function:Child C.
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 |
|---|---|---|
| TACE+TegafurAlso: TACE followed by TegafurTegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection. | Procedure or surgery | TACE+ Tegafur |
| TACETACE alone | Procedure or surgery | TACE |
Primary outcome
Overall survival rates of each group
Time frame: 3 years
1 secondary outcome
Occurrence rate of recurrence of each group
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
Related trials for Intrahepatic Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 2
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Liver Cancer, Intrahepatic Cholangiocarcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE+Tegafur and TACE in people with Intrahepatic Cholangiocarcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
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 5 inclusion and 5 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 31 Mar 2016. 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 China. 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 Wang Kui, MD (+86-021-81875242, wangkuiykl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rates of each group (time frame: 3 years). 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 31 Mar 2016.