Colorectal CancerPhase 3NCT05540951
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
A Phase 3 study testing VIC and Bevacizumab Plus Chemotherapy in people with Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival. 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?
- VIC and Bevacizumab Plus Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤80 years old
- Histologically confirmed colorectal adenocarcinoma
- Histologically confirmed BRAFV600E mutated and RAS wild-type
- Initially unresectable metastatic or local CRC
- ECOG performance status of 0-1 and life expectancy ≥3 months
- adequate hepatic, renal, and hematologic function
Who cannot join
- Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months
- Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai
Jianmin Xu, MD, 86-21-6404-1990 ext. 3449, xujmin@aliyun.com
About this study
Official title: VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.
- Conditions
- Colorectal Cancer
- Being tested
- VIC, Bevacizumab Plus Chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VICDrug
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)
Bevacizumab Plus ChemotherapyDrug
Bevacizumab Plus Doublet or Triplet Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| VIC | Experimental | VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Receives: Drug: VIC |
| BEV | Active comparator | Bevacizumab Plus Chemotherapy Receives: Drug: Bevacizumab Plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
time from first study treatment to the first documented progression disease or death, whichever occurred first
Measured: 3 years
overall survival
time from first study treatment to death from any cause.
Measured: 3 years
objective response rate
the proportion of patients with complete response or partial response.
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 posted15 Sep 2022
- Study start1 Jun 2018
- Primary completion30 Aug 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540951
- Sponsor's protocol ID
- VICBEV
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 15 Sep 2022
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05540951
- Acronym / sponsor ID
- VICBEV
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Sep 2022 (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.
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIC | Experimental | Drug: VICVIC Regimen (Vemurafenib/Irinotecan/Cetuximab) |
| BEV | Active comparator | Drug: Bevacizumab Plus ChemotherapyBevacizumab Plus Chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤80 years old
- Histologically confirmed colorectal adenocarcinoma
- Histologically confirmed BRAFV600E mutated and RAS wild-type
- Initially unresectable metastatic or local CRC
- ECOG performance status of 0-1 and life expectancy ≥3 months
Key exclusion criteria (2 listed)
- Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months
- Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.
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 |
|---|---|---|
| VICVIC Regimen (Vemurafenib/Irinotecan/Cetuximab) | Drug | VIC |
| Bevacizumab Plus ChemotherapyBevacizumab Plus Doublet or Triplet Chemotherapy | Drug | BEV |
Primary outcome
progression-free survival
Time frame: 3 years
time from first study treatment to the first documented progression disease or death, whichever occurred first
overall survival
Time frame: 3 years
time from first study treatment to death from any cause.
objective response rate
Time frame: 6 months
the proportion of patients with complete response or partial response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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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?
A Phase 3 study testing VIC and Bevacizumab Plus Chemotherapy in people with Colorectal 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 6 inclusion and 2 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 15 Sep 2022. 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, MD (86-21-6404-1990 ext. 3449, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 3 years). The study lists 3 primary outcomes in all. 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 15 Sep 2022.