Colorectal Adenocarcinoma Metastatic to the LiverPhase 3NCT03783559
TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
A Phase 3 study testing TACE and chemotherapy±target therapy in people with Colorectal Adenocarcinoma Metastatic to the Liver, run by Fudan University at 1 site in China.
Trial summary
To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Adenocarcinoma Metastatic to the Liver
- What is being tested?
- TACE and chemotherapy±target therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Mar 2021
- Phase
- Phase 3
- 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
- Patients must have histologically confirmed CRLM
- disease limited to the liver Unresectable disease by surgery or other local therapies
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B
- Expected survival ≥ 3 months
- Adequate hematological, hepatic and renal function
- PD(progressive disease) after first line chemotherapy
Who cannot join
- pregnant or lactating women
- patients with severe organ dysfunction or failure
- with severe cardiovascular or mental disease
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, 200032
About this study
Official title: TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy
To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.
- Being tested
- TACE, chemotherapy±target therapy
- Keywords
- colorectal cancer liver metastasis, Transarterial chemoembolization, conversion resection rates, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEDrug
TACE
chemotherapy±target therapyDrug
chemotherapy±target therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | TACE plus chemotherapy ± target therapy Receives: Drug: TACE; Drug: chemotherapy±target therapy |
| Arm B | Active comparator | chemotherapy ± target therapy Receives: Drug: chemotherapy±target therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 6 months
Secondary outcomes (2)
overall survival
Measured: 6 months
conversion resection rates
Measured: 2-4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study startJan 2016
- Primary completionDec 2018
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Adenocarcinoma Metastatic to the LiverStudies of the same condition, open and under way.
- More trials run by Fudan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783559
- Sponsor's protocol ID
- TACECRLM
- Status last verified
- Jun 2019
- First submitted
- 15 Dec 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Chang W, Zhou B, Wei Y, Tang W, Liang F, Chen Y, Yan Z, Lv M, Ren L, Xu J. Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):373-379. doi: 10.1093/bjs/znaa155.
PubMed 33611431Swierz MJ, Storman D, Riemsma RP, Wolff R, Mitus JW, Pedziwiatr M, Kleijnen J, Bala MM. Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. Cochrane Database Syst Rev. 2020 Mar 12;3(3):CD009498. doi: 10.1002/14651858.CD009498.pub4.
PubMed 32163181
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT03783559
- Acronym / sponsor ID
- TACECRLM
- Keywords
- colorectal cancer liver metastasis, Transarterial chemoembolization, conversion resection rates, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Dec 2018 (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.
To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: TACE, Drug: chemotherapy±target therapyTACE plus chemotherapy ± target therapy |
| Arm B | Active comparator | Drug: chemotherapy±target therapychemotherapy ± target therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have histologically confirmed CRLM
- disease limited to the liver Unresectable disease by surgery or other local therapies
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B
- Expected survival ≥ 3 months
Key exclusion criteria (3 listed)
- pregnant or lactating women
- patients with severe organ dysfunction or failure
- with severe cardiovascular or mental disease
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 |
|---|---|---|
| TACETACE | Drug | Arm A |
| chemotherapy±target therapychemotherapy±target therapy | Drug | Arm A, Arm B |
Primary outcome
Progression free survival
Time frame: 6 months
2 secondary outcomes
overall survival
Time frame: 6 months
conversion resection rates
Time frame: 2-4months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 33611431Liu Y, Chang W, Zhou B, Wei Y, Tang W, Liang F, Chen Y, Yan Z, Lv M, Ren L, Xu J. Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):373-379. doi: 10.1093/bjs/znaa155.
- Derived from this study: PubMed 32163181Swierz MJ, Storman D, Riemsma RP, Wolff R, Mitus JW, Pedziwiatr M, Kleijnen J, Bala MM. Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. Cochrane Database Syst Rev. 2020 Mar 12;3(3):CD009498. doi: 10.1002/14651858.CD009498.pub4.
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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.
Jianmin Xu, PhD study chair
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 3 study testing TACE and chemotherapy±target therapy in people with Colorectal Adenocarcinoma Metastatic to the Liver, run by Fudan University 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 7 inclusion and 3 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 12 Jun 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03783559, which also lists 2 linked publications.
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 12 Jun 2019.