Colorectal CancerPhase 2cellcolNCT03803241
Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
A Phase 2 study testing CD133+ infusion and portal vein embolization in people with Colorectal Cancer, run by Hospital San Carlos, Madrid at 2 sites in Spain.
Trial summary
Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rises 10-13% more. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CD133+ infusion and portal vein embolization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesSpain
- Study dates
- 31 May 2019to 30 Jun 2021
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between ≥ 18 years and ≤ 80. Women in fertile age should use contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG).
- ECOG (Eastern Cooperative Oncology Group) quality of life scale ≤ 2.
- Patients with hepatic metastases of colorectal carcinoma and insufficient hepatic remnant function to perform a major hepatectomy. This volume would be calculated by Positron emission tomography-Computed tomography (PET-CT) images or 64-channel multidetector CT.
- In patients who have received preoperative chemotherapy, the estimate residual liver volume to be included in the study will be <40%.
- Patients who have preserved liver function (Child ≤ B7 and International Normalized Ratio (INR) ≤ 2 in non-anticoagulated patients) and those who have not received chemotherapy, needs < 30% of residual volume to be included in the study.
- Patients should have signed informed consent.
Who cannot join
- Pregnancy or lactation period.
- Any condition that the investigators consider an unjustifiable risk in the patient.
- Severe comorbidities: American Society of Anesthesiologists (ASA) ≥ 4.
- Alterations in the hemogram and morphological alterations, evaluated by hematologist prior to administration of G-CSF.
- Liver function: Child ≥ B7 and INR ≥ 2 in non-anticoagulated patients. In anticoagulated patients the values will have to be reverse, prior to surgery.
- Patients who have not received research drugs in the last 30 days or in the period of 5 elimination half-life.
- In patients on chemotherapy treatment, G-CSF can not be administered until 48 hours after the last administration of chemotherapy. Patients who have received Bevacizumab must wait 30 days since the last administration.
- In addition, all those aspects that prevent the patient from being part of the study, understand the rules, follow the instructions given, or other aspects.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinico San Carlos
Madrid, 28031
Alejandra Garcia Botella
Madrid, 28040
About this study
Official title: Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection
Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rises 10-13% more. To perform the surgery it is necessary to have a sufficient remnant liver volume (RLV), which allows maintaining optimal liver function after resection. If the estimated RLV is insufficient preoperatively, portal venous embolization site (PVE) is performed for compensatory hypertrophy, thus increasing the number of resections 19%. Still, in 20% of these patients surgery can not be performed because RLV is not achieved or because the disease progresses while waiting for growth. Therefore, it is necessary to improve liver regeneration without promoting tumor growth. Studies on liver regeneration, have determined that cells (CD133 +) are involved in the liver hypertrophy that occurs after hepatectomy. CD133 + have been used to induce liver hypertrophy with encouraging results. This population of CD133 +, can be selected from peripheral blood after stimulation with Granulocyte colony-stimulating factor (G-CSF), being able to obtain a large number of them. The investigators propose to treat patients who do not meet criteria for surgery because of insufficient volume <40%, with CD133 + and portal embolization in order to carry out a surgical resection in a second place.
- Conditions
- Colorectal Cancer
- Being tested
- CD133+ infusion, portal vein embolization
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD133+ infusionDrug
Infusion of cells cd133+
portal vein embolizationOther
portal vein embolization
| Study group | Role | What they receive |
|---|---|---|
| PVE + CD133 | Experimental | preop portal vein embolization + stem cells infusion Receives: Drug: CD133+ infusion; Other: portal vein embolization |
| PVE | Sham comparator | only preop portal vein embolization Receives: Other: portal vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver volume
Liver volume estimated by computed tomography
Measured: once residual liver volume reach >40%, an average of 5 weeks.
Secondary outcomes (6)
Liver volume
Liver volume estimated by computed tomography
Measured: Post-surgery follow-up visits the first 30 days
Liver volume
Liver volume estimated by computed tomography
Measured: Post-surgery follow-up visits the first 90 days
Liver volume
Liver volume estimated by computed tomography
Measured: Post-surgery follow-up visits the first 180 days
Liver volume
Liver volume estimated by computed tomography
Measured: Post-surgery follow-up visits the first 12 months
Liver volume
Liver volume estimated by computed tomography
Measured: Post-surgery follow-up visits the first 18 months
Liver volume
Liver volume estimated by computed tomography
Measured: Post-surgery follow-up visits the first 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start31 May 2019
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Garcia Botella, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803241
- Sponsor's protocol ID
- 2014-001402-18
- Other IDs
- 2014
- Acronym
- cellcol
- Status last verified
- Sep 2021
- First submitted
- 18 Nov 2016
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia-Botella A, Saez-Carlin P, Mendez R, Martin MP, Ortega L, Mendez JV, Garcia-Paredes B, Diez-Valladares L, Torres AJ. CD133 + cell infusion in patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL): A randomized open label clinical trial. Surg Oncol. 2020 Jun;33:224-230. doi: 10.1016/j.suronc.2019.10.005. Epub 2019 Oct 7.
PubMed 32561087
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection
- ClinicalTrials.gov ID
- NCT03803241
- Acronym / sponsor ID
- cellcol / 2014-001402-18
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Jan 2019 (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.
Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rises 10-13% more. To perform the surgery it is necessary to have a sufficient remnant liver volume (RLV), which allows maintaining optimal liver function after resection. If the estimated RLV is insufficient preoperatively, portal venous embolization site (PVE) is performed for compensatory hypertrophy, thus increasing the number of resections 19%. Still, in 20% of these patients surgery can not be performed because RLV is not achieved or because the disease progresses while waiting for growth. Therefore, it is necessary to improve liver regeneration without promoting tumor growth. Studies on liver regeneration, have determined that cells (CD133 +) are involved in the liver hypertrophy that occurs after hepatectomy. CD133 + have been used to induce liver hypertrophy with encouraging results. This population of CD133 +, can be selected from peripheral blood after stimulation with Granulocyte colony-stimulating factor (G-CSF), being able to obtain a large number of them. The investigators propose to treat patients who do not meet criteria for surgery because of insufficient volume <40%, with CD133 + and portal embolization in order to carry out a surgical resection in a second place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVE + CD133 | Experimental | Drug: CD133+ infusion, Other: portal vein embolizationpreop portal vein embolization + stem cells infusion |
| PVE | Sham comparator | Other: portal vein embolizationonly preop portal vein embolization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women between ≥ 18 years and ≤ 80. Women in fertile age should use contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG).
- ECOG (Eastern Cooperative Oncology Group) quality of life scale ≤ 2.
- Patients with hepatic metastases of colorectal carcinoma and insufficient hepatic remnant function to perform a major hepatectomy. This volume would be calculated by Positron emission tomography-Computed tomography (PET-CT) images or 64-channel multidetector CT.
- In patients who have received preoperative chemotherapy, the estimate residual liver volume to be included in the study will be <40%.
- Patients who have preserved liver function (Child ≤ B7 and International Normalized Ratio (INR) ≤ 2 in non-anticoagulated patients) and those who have not received chemotherapy, needs < 30% of residual volume to be included in the study.
Key exclusion criteria (8 listed)
- Pregnancy or lactation period.
- Any condition that the investigators consider an unjustifiable risk in the patient.
- Severe comorbidities: American Society of Anesthesiologists (ASA) ≥ 4.
- Alterations in the hemogram and morphological alterations, evaluated by hematologist prior to administration of G-CSF.
- Liver function: Child ≥ B7 and INR ≥ 2 in non-anticoagulated patients. In anticoagulated patients the values will have to be reverse, prior to surgery.
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 |
|---|---|---|
| CD133+ infusionInfusion of cells cd133+ | Drug | PVE + CD133 |
| portal vein embolizationportal vein embolization | Other | PVE, PVE + CD133 |
Primary outcome
Liver volume
Time frame: once residual liver volume reach >40%, an average of 5 weeks.
Liver volume estimated by computed tomography
6 secondary outcomes
Liver volume
Time frame: Post-surgery follow-up visits the first 30 days
Liver volume
Time frame: Post-surgery follow-up visits the first 90 days
Liver volume
Time frame: Post-surgery follow-up visits the first 180 days
Liver volume
Time frame: Post-surgery follow-up visits the first 12 months
Liver volume
Time frame: Post-surgery follow-up visits the first 18 months
Liver volume
Time frame: Post-surgery follow-up visits the first 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 32561087Garcia-Botella A, Saez-Carlin P, Mendez R, Martin MP, Ortega L, Mendez JV, Garcia-Paredes B, Diez-Valladares L, Torres AJ. CD133 + cell infusion in patients with colorectal liver metastases going to be submitted to a major liver resection (CELLCOL): A randomized open label clinical trial. Surg Oncol. 2020 Jun;33:224-230. doi: 10.1016/j.suronc.2019.10.005. Epub 2019 Oct 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD133+ infusion and portal vein embolization in people with Colorectal Cancer, run by Hospital San Carlos, Madrid at 2 sites in Spain.
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 8 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: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Liver volume (time frame: once residual liver volume reach >40%, an average of 5 weeks.). 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 NCT03803241, which also lists 1 linked publication.
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 27 Sep 2021.