Colorectal CancerPhase 3NCT04525326
Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
A Phase 3 study testing Cetuximab, Bevacizumab and mFOLFOX/FOLFIRI ( Standard Chemotherapy) in people with Colorectal Cancer and Liver Metastases, run by Fudan University.
Trial summary
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Cetuximab, Bevacizumab and mFOLFOX/FOLFIRI ( Standard Chemotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Nov 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
- The primary tumor was confirmed by histology as colorectal adenocarcinoma
- primary right-sided colorectal adenocarcinoma
- Radiologic evidence suggests that the initial unresectable liver metastases
- RAS/BRAF gene wild-type states
- ECOG was 0 ~ 1
- Life expectancy ≥ 3 months
Show all 9Show fewer
- Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
- Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
- Sign the written informed consent to participate in the experiment
Who cannot join
- Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
- Known or suspected extrahepatic metastasis
- Patients with known hypersensitivity to any component of the study treatment
- Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
- Acute or subacute intestinal obstruction
- Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
Show all 10Show fewer
- She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
- Known drug / alcohol abuse
- No legal capacity or limited legal capacity
- There is peripheral neuropathy
About this study
Official title: A Prospective Study on the Conversion Therapy of Ras / BRAF Wild Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases: Standard Chemotherapy Plus Cetuximab VS. Standard Chemotherapy Plus Bevacizumab
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer.
Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Cetuximab, Bevacizumab, mFOLFOX/FOLFIRI ( Standard Chemotherapy)
- Keywords
- Cetuximab, Bevacizumab, Liver Metastases, Colorectal Cancer, right-sided
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
mFOLFOX+Cetuximab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
BevacizumabDrug
mFOLFOX+Bevacizumab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
mFOLFOX/FOLFIRI ( Standard Chemotherapy)Drug
Standard Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| standard chemotherapy plus Cetuximab | Experimental | Not described Receives: Drug: Cetuximab; Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy) |
| standard chemotherapy plus Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab; Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion liver resection rate
Rate of conversion from initially unresectable liver metastases to resectable ones
Measured: up to 6 months
Secondary outcomes (4)
objective response rate
rate of objective response for therapy(according to RECIST 1.0)
Measured: up to 6 months
Incidence of adverse events
Incidence of adverse events
Measured: up to 6 months
Progression free survival
Progression free survival
Measured: up to 3 years
overall survival
overall survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525326
- Sponsor's protocol ID
- SHENKANG2020XU
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Conversion Therapy of Ras / BRAF Wild Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases: Standard Chemotherapy Plus Cetuximab VS. Standard Chemotherapy Plus Bevacizumab
- ClinicalTrials.gov ID
- NCT04525326
- Acronym / sponsor ID
- SHENKANG2020XU
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- Cetuximab, Bevacizumab, Liver Metastases, Colorectal Cancer, right-sided
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 25 Aug 2020 (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.
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer.
Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard chemotherapy plus Cetuximab | Experimental | Drug: Cetuximab, Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy) |
| standard chemotherapy plus Bevacizumab | Experimental | Drug: Bevacizumab, Drug: mFOLFOX/FOLFIRI ( Standard Chemotherapy) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The primary tumor was confirmed by histology as colorectal adenocarcinoma
- primary right-sided colorectal adenocarcinoma
- Radiologic evidence suggests that the initial unresectable liver metastases
- RAS/BRAF gene wild-type states
- ECOG was 0 ~ 1
Key exclusion criteria (10 listed)
- Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
- Known or suspected extrahepatic metastasis
- Patients with known hypersensitivity to any component of the study treatment
- Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
- Acute or subacute intestinal obstruction
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 |
|---|---|---|
| CetuximabmFOLFOX+Cetuximab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis | Drug | standard chemotherapy plus Cetuximab |
| BevacizumabmFOLFOX+Bevacizumab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis | Drug | standard chemotherapy plus Bevacizumab |
| mFOLFOX/FOLFIRI ( Standard Chemotherapy)Standard Chemotherapy | Drug | standard chemotherapy plus Bevacizumab, standard chemotherapy plus Cetuximab |
Primary outcome
Conversion liver resection rate
Time frame: up to 6 months
Rate of conversion from initially unresectable liver metastases to resectable ones
4 secondary outcomes
objective response rate
Time frame: up to 6 months
Incidence of adverse events
Time frame: up to 6 months
Progression free survival
Time frame: up to 3 years
overall survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab, Bevacizumab and mFOLFOX/FOLFIRI ( Standard Chemotherapy) in people with Colorectal Cancer and Liver Metastases, run by Fudan University.
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 9 inclusion and 10 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Conversion liver resection rate (time frame: up to 6 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 25 Aug 2020.