Colon CancerROBOTNCT04213222
Radiomics Assess of Bevacizumab Plus Chemo in Colorectal Cancer Liver Metastases
An observational study of Colon Cancer and Rectal Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Liver Metastases
- What is being tested?
- Bevacizumab
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2020to Dec 2023
- Phase
- Observational
- 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
Study population: Patients of colorectal carcinoma with liver metastasis
Who may be able to join
- Colorectal carcinoma confirmed by pathological result.
- Liver metastasis confirmed by imaging studies.
- Treatment of bevacizumab combined with chemotherapy chosen by MDT team.
- ECOG: 0-2.
- Normal laboratory studies including liver\renal\bone marrow functions.
- Expected lifespan more than 3 months.
Who cannot join
- Previous treatment of colorectal cancer with liver metastasis.
- Diagnosed with other malignancies.
- Couldn't finish the trial due to several reasons such as allergy to chemotherapy drugs\pregnancy or lactation\chronic heart disease\unable to sustain further treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yudi Bao, MD, ggpptang@gmail.com
About this study
Official title: A Radiomics Approach to Predict the Effect of Bevacizumab Plus Chemotherapy in Patients With Liver Metastases of Colorectal Cancer: A Prospective Multi-Centers Trial
Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. This study is aiming to find out the specific type of patients who would respond to bevacizumab by Radiomics approach, and evaluate the prediction value of this imaging model with clinical and genetic factors.
- Conditions
- Colon Cancer, Rectal Cancer, Liver Metastases
- Being tested
- Bevacizumab
- Keywords
- colorectal cancer, liver metastasis, bevacizumab
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
bevacizumab combined with chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated ORR
Measured: 6-8 weeks
Secondary outcomes (2)
estimated PFS
Measured: 3 years
estimated OS
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 posted30 Dec 2019
- Study startOct 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213222
- Sponsor's protocol ID
- 20181113
- Acronym
- ROBOT
- Status last verified
- Aug 2020
- First submitted
- 25 Dec 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radiomics Approach to Predict the Effect of Bevacizumab Plus Chemotherapy in Patients With Liver Metastases of Colorectal Cancer: A Prospective Multi-Centers Trial
- ClinicalTrials.gov ID
- NCT04213222
- Acronym / sponsor ID
- ROBOT / 20181113
- Conditions
- Colon Cancer, Rectal Cancer, Liver Metastases
- Keywords
- colorectal cancer, liver metastasis, bevacizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Dec 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.
Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. This study is aiming to find out the specific type of patients who would respond to bevacizumab by Radiomics approach, and evaluate the prediction value of this imaging model with clinical and genetic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of colorectal carcinoma with liver metastasis
Key inclusion criteria (6 listed)
- Colorectal carcinoma confirmed by pathological result.
- Liver metastasis confirmed by imaging studies.
- Treatment of bevacizumab combined with chemotherapy chosen by MDT team.
- ECOG: 0-2.
- Normal laboratory studies including liver\renal\bone marrow functions.
Key exclusion criteria (3 listed)
- Previous treatment of colorectal cancer with liver metastasis.
- Diagnosed with other malignancies.
- Couldn't finish the trial due to several reasons such as allergy to chemotherapy drugs\pregnancy or lactation\chronic heart disease\unable to sustain further treatment.
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 |
|---|---|---|
| Bevacizumabbevacizumab combined with chemotherapy | Drug | – |
Primary outcome
estimated ORR
Time frame: 6-8 weeks
2 secondary outcomes
estimated PFS
Time frame: 3 years
estimated OS
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 11 Aug 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectal Cancer, run by Peking University People's 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 6 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 11 Aug 2020. 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 Yudi Bao, MD (8613810355879, ggpptang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimated ORR (time frame: 6-8 weeks). 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 11 Aug 2020.