Colorectal Adenocarcinoma Metastatic to the LiverPhase 3NCT03125161
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
A Phase 3 study testing HAI 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 prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. 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?
- HAI and chemotherapy ± target therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2017to 31 Dec 2020
- 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
- All patients must meet the following criteria:
- Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
- Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age > 18 years
- Subject life expectancy > 3 months
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- Platelets > 100×103/mm3
- Total bilirubin <1.5mg/dl
- Creatinine level < 2.0 mg/dl
- All patients must sign an informed consent form
Who cannot join
- The CRLM is amenable to curative surgical therapy
- Prior radiation, TACE or HAI to the liver
- Uncorrectable coagulopathy
- Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
- Current or planned treatment with any experimental chemotherapy or target drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hosptial, Fudan University
Shanghai, 200032
Jianmin Xu, PhD, +86-13501984869, xujmin@aiiyun.com
About this study
Official title: A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases
To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
- Being tested
- HAI, chemotherapy ± target therapy
- Keywords
- colorectal cancer, liver metastasis, hepatic arterial infusion, chemotherapy, target therapy, conversional resection rates
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAIDrug
HAI
chemotherapy ± target therapyDrug
chemotherapy ± target therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | HAI plus chemotherapy ± target therapy Receives: Drug: HAI; 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.
conversional resection rates
Measured: 2-4 months
Secondary outcomes (1)
overall response rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start30 Apr 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 150 participants (estimated)
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
- NCT03125161
- Sponsor's protocol ID
- HAICRLM
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT03125161
- Acronym / sponsor ID
- HAICRLM
- Keywords
- colorectal cancer, liver metastasis, hepatic arterial infusion, chemotherapy, target therapy, conversional resection rates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Apr 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Apr 2017 (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 prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
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: HAI, Drug: chemotherapy ± target therapyHAI 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 (10 listed)
- All patients must meet the following criteria:
- Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
- Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age > 18 years
Key exclusion criteria (5 listed)
- The CRLM is amenable to curative surgical therapy
- Prior radiation, TACE or HAI to the liver
- Uncorrectable coagulopathy
- Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
- Current or planned treatment with any experimental chemotherapy or target drugs
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 |
|---|---|---|
| HAIHAI | Drug | Arm A |
| chemotherapy ± target therapychemotherapy ± target therapy | Drug | Arm A, Arm B |
Primary outcome
conversional resection rates
Time frame: 2-4 months
1 secondary outcome
overall response rates
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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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 HAI 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 10 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 24 Apr 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 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?
Contact Jianmin Xu, PhD (+86-13501984869, xujmin@aiiyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversional resection rates (time frame: 2-4 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 24 Apr 2017.