Colorectal Cancer MetastaticPhase 4TACENCT01959061
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
A Phase 4 study testing Raltitrexed, Oxaliplatin and lipiodol in people with Colorectal Cancer Metastatic, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Raltitrexed, Oxaliplatin and lipiodol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2017
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma
- Disease limited to the liver Unresectable disease by surgery or other local therapies
- Age >18 years
- ECOG performance status 0-2,Child pugh A or B
- Expected survival ≥ 3 months
- Adequate hematological, hepatic, and renal function
Who cannot join
- Pregnant or lactating women
- Patients with severe organ dysfunction or failure
- With severe cardiovascular disease, or mental
- Extraliver metastases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 2000032
Jianhua Wang
About this study
Official title: Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer
Read the detailed description
evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Raltitrexed, Oxaliplatin, lipiodol
- Keywords
- Advanced colorectal cancer of liver metastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltitrexedDrug
4mg, every 4 weeks,transhepatic arterial infusion
OxaliplatinDrug
100~150mg, every 4 weeks, transhepatic arterial infusion
lipiodolDrug
5-20ml, every 4 weeks, hepatic artery embolization
| Study group | Role | What they receive |
|---|---|---|
| Raltitrexed and Oxaliplatin | Experimental | Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle. Receives: Drug: Raltitrexed; Drug: Oxaliplatin; Drug: lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survivial
From date of randomization until date of first documented PD, date of death
Measured: 8 months after last patient randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startSep 2013
- 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 Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianhua Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959061
- Sponsor's protocol ID
- NJCTTQ-01
- Acronym
- TACE
- Status last verified
- Mar 2017
- First submitted
- 18 Sep 2013
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01959061
- Acronym / sponsor ID
- TACE / NJCTTQ-01
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Advanced colorectal cancer of liver metastatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Oct 2013 (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.
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer
Detailed description
evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltitrexed and Oxaliplatin | Experimental | Drug: Raltitrexed, Drug: Oxaliplatin, Drug: lipiodolRaltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed colorectal adenocarcinoma
- Disease limited to the liver Unresectable disease by surgery or other local therapies
- Age >18 years
- ECOG performance status 0-2,Child pugh A or B
- Expected survival ≥ 3 months
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients with severe organ dysfunction or failure
- With severe cardiovascular disease, or mental
- Extraliver metastases
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 |
|---|---|---|
| Raltitrexed4mg, every 4 weeks,transhepatic arterial infusion | Drug | Raltitrexed and Oxaliplatin |
| Oxaliplatin100~150mg, every 4 weeks, transhepatic arterial infusion | Drug | Raltitrexed and Oxaliplatin |
| lipiodol5-20ml, every 4 weeks, hepatic artery embolization | Drug | Raltitrexed and Oxaliplatin |
Primary outcome
Progression-free survivial
Time frame: 8 months after last patient randomized
From date of randomization until date of first documented PD, date of death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jianhua Wang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltitrexed, Oxaliplatin and lipiodol in people with Colorectal Cancer Metastatic, run by Nanjing Chia-tai Tianqing Pharmaceutical 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 6 inclusion and 4 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 13 Mar 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianhua Wang (021-64041990, wang.jianhua@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survivial (time frame: 8 months after last patient randomized). 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 13 Mar 2017.