Liver Metastasis Colon CancerPhase 2NCT04832776
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
A Phase 2 study testing Cetuximab, Bevacizumab and FOLFOXIRI in people with Liver Metastasis Colon Cancer, run by Fudan University at 1 site in China.
Trial summary
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Metastasis Colon Cancer
- What is being tested?
- Cetuximab, Bevacizumab and FOLFOXIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2021to 31 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG perfomance 0-1
- pathologically confirmed colorectal carcinoma, with RAS wild type
- inital unresectable liver metastases discussed by MDT
- prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
- without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
- adequate blood, liver and renal function
- expected survival longer than 6 months
Who cannot join
- with bleeding risk
- interestinal obstruction or disease
- uncontrolled hypertension and severe heart disease
- previous severe thrombotic events
- central nervous system metastases
- accompanied with other malignant tumor
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Colorectal Surgery Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Sanjun Cai, M.D, +86-21-64175590 ext. 81108, caisanjuncsj@163.com
About this study
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases
- Conditions
- Liver Metastasis Colon Cancer
- Being tested
- Cetuximab, Bevacizumab, FOLFOXIRI
- Keywords
- FOLFOXIRI, cetuximab, bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
one group plus cetuximab
BevacizumabDrug
one group plus bevacizumab
FOLFOXIRIDrug
FOLFOXIRI
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI+C225 | Experimental | Not described Receives: Drug: Cetuximab; Drug: FOLFOXIRI |
| FOLFOXIRI+BEV | Active comparator | Not described Receives: Drug: Bevacizumab; Drug: FOLFOXIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: up to 8 weeks
Secondary outcomes (4)
R0 resection rate of liver metastases
R0 resection rate of liver metastases
Measured: up to 8 weeks
NED rate
percentage of patients who reach NED
Measured: up to 8 weeks
OS
overal survival
Measured: up to 6 months
PFS
progression free survival
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start17 Apr 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastasis Colon CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjun Cai, Fudan University
- Investigators
- Wen Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832776
- Sponsor's protocol ID
- Cetu-Bev-FOLFOXIRI
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT04832776
- Acronym / sponsor ID
- Cetu-Bev-FOLFOXIRI
- Conditions
- Liver Metastasis Colon Cancer
- Keywords
- FOLFOXIRI, cetuximab, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Apr 2021 (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 compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI+C225 | Experimental | Drug: Cetuximab, Drug: FOLFOXIRI |
| FOLFOXIRI+BEV | Active comparator | Drug: Bevacizumab, Drug: FOLFOXIRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG perfomance 0-1
- pathologically confirmed colorectal carcinoma, with RAS wild type
- inital unresectable liver metastases discussed by MDT
- prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
- without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
Key exclusion criteria (6 listed)
- with bleeding risk
- interestinal obstruction or disease
- uncontrolled hypertension and severe heart disease
- previous severe thrombotic events
- central nervous system 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 |
|---|---|---|
| Cetuximabone group plus cetuximab | Drug | FOLFOXIRI+C225 |
| Bevacizumabone group plus bevacizumab | Drug | FOLFOXIRI+BEV |
| FOLFOXIRIFOLFOXIRI | Drug | FOLFOXIRI+BEV, FOLFOXIRI+C225 |
Primary outcome
ORR
Time frame: up to 8 weeks
objective response rate
4 secondary outcomes
R0 resection rate of liver metastases
Time frame: up to 8 weeks
NED rate
Time frame: up to 8 weeks
OS
Time frame: up to 6 months
PFS
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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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.
Wen Zhang 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 2 study testing Cetuximab, Bevacizumab and FOLFOXIRI in people with Liver Metastasis Colon Cancer, 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 6 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 6 Apr 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenhua Li (13817922257 ext. 13817922257, whliiris@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 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 6 Apr 2021.