Colo-rectal CancerPhase 2CAPCETNCT05022030
First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes
A Phase 2 study testing mCapOX plus cetuximab and mFOLFOX6 plus cetuximab in people with Colo-rectal Cancer and Capecitabine, run by West China Hospital at 1 site in China.
Trial summary
This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Capecitabine, Cetuximab
- What is being tested?
- mCapOX plus cetuximab and mFOLFOX6 plus cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2021to 1 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and can understand and comply with the requirements of the study;
- Men and women ≥ 18 years of age;
- Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;
- Presence of at least one evaluable lesion, as defined in RECIST Version 1.1;
- With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy;
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- According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) ;
- Life expectancy of longer than 3 months ( clinical assessment);
- Requirements for lab indicators neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, hemoglobin ≥ 8 g/dL, total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH < 1500 U/L; creatinine clearance (calculated according to Cockcroft and Gault formula) > 50 mL/min or serum creatinine ≤ 1.5 × UNL;
Who cannot join
- Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.
- Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
- Hypersensitivity to any therapeutic agent.
- Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study;
- Patients who have failed one or more palliative chemotherapy regimens;
- Patients with uncontrolled hepatitis B virus
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- Peripheral neuropathy ≥ CTC grade 2;
- Neurological or psychiatric disorders affecting cognitive performance;
- Patients with central nervous system metastasis could not be controlled with radiotherapy;
- Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation
- Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.;
- Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures;
- History of other malignancies, but no disease-free survival longer than 5 years;
- Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials;
- Patients who are unable to comply with this study for psychological, family or social reasons.
- Patients with other serious diseases that the investigator considers not suitable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xiaofen Li, M.D., +86-28-85422589, lxf0827@163.com
About this study
Official title: First-line Treatment of mCapOX Plus Cetuximab Versus mFOLFOX6 Plus Cetuximab for Metastatic Left-sided CRC Patients With Wild-type RAS/BRAF Genes: a Multicenter, Randomised, Phase 2 Study
This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.
Read the detailed description
The patients, who meet the inclusion criteria and have signed the informed consent, will be randomly assigned (1:1 ratio) to receive mCapOX plus cetuximab regimen (arm A) and mFOLFOX6 plus cetuximab regimen (arm B).
- Conditions
- Colo-rectal Cancer, Capecitabine, Cetuximab
- Being tested
- mCapOX plus cetuximab, mFOLFOX6 plus cetuximab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCapOX plus cetuximabDrug
capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w
mFOLFOX6 plus cetuximabDrug
oxaliplatin ivgtt 85mg/m2 d1+ leucovorin ivgtt 400mg/m2 d1+ fluorouracil iv bolus 400mg/m2 d1+ fluorouracil 2400mg/m2 continuous infusion for 46h+cetuximab ivgtt 500mg/m2, q2w
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | mCapOX (capecitabine+oxaliplatin) plus cetuximab Receives: Drug: mCapOX plus cetuximab |
| Arm B | Active comparator | mFOLFOX6 (fluorouracil+leucovorin+oxaliplatin) plus cetuximab Receives: Drug: mFOLFOX6 plus cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) rate at 9 months
PFS rate at 9 months is defined as the proportion of patients without PD or death at 9 months after randomization.
Measured: 9 months
Secondary outcomes (5)
Objective response rate
The rate of complete response and partial response
Measured: 6 months
Disease control rate
The rate of complete response, partial response and stable disease.
Measured: 6 months
Progression free survival
Progression free survival is defined as the period from randomization to disease progress or death.
Measured: up to 3 years
Overall survival
Overall survial is defined as the period from randomization to death.
Measured: up to 4 years
Adverse event rate
The rate of adverse event after treatment
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 posted26 Aug 2021
- Study start21 Jul 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by West China 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Qiu, West China Hospital
- Investigators
- Meng Qiu, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022030
- Sponsor's protocol ID
- 20210602
- Acronym
- CAPCET
- Status last verified
- Mar 2024
- First submitted
- 23 Aug 2021
- Last updated
- 7 Mar 2024
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Treatment of mCapOX Plus Cetuximab Versus mFOLFOX6 Plus Cetuximab for Metastatic Left-sided CRC Patients With Wild-type RAS/BRAF Genes: a Multicenter, Randomised, Phase 2 Study
- ClinicalTrials.gov ID
- NCT05022030
- Acronym / sponsor ID
- CAPCET / 20210602
- Conditions
- Colo-rectal Cancer, Capecitabine, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Aug 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.
This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.
Detailed description
The patients, who meet the inclusion criteria and have signed the informed consent, will be randomly assigned (1:1 ratio) to receive mCapOX plus cetuximab regimen (arm A) and mFOLFOX6 plus cetuximab regimen (arm B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: mCapOX plus cetuximabmCapOX (capecitabine+oxaliplatin) plus cetuximab |
| Arm B | Active comparator | Drug: mFOLFOX6 plus cetuximabmFOLFOX6 (fluorouracil+leucovorin+oxaliplatin) plus cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to provide written informed consent and can understand and comply with the requirements of the study;
- Men and women ≥ 18 years of age;
- Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;
- Presence of at least one evaluable lesion, as defined in RECIST Version 1.1;
- With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
Key exclusion criteria (16 listed)
- Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.
- Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
- Hypersensitivity to any therapeutic agent.
- Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study;
- Patients who have failed one or more palliative chemotherapy regimens;
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 |
|---|---|---|
| mCapOX plus cetuximabcapecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w | Drug | Arm A |
| mFOLFOX6 plus cetuximaboxaliplatin ivgtt 85mg/m2 d1+ leucovorin ivgtt 400mg/m2 d1+ fluorouracil iv bolus 400mg/m2 d1+ fluorouracil 2400mg/m2 continuous infusion for 46h+cetuximab ivgtt 500mg/m2, q2w | Drug | Arm B |
Primary outcome
Progression free survival (PFS) rate at 9 months
Time frame: 9 months
PFS rate at 9 months is defined as the proportion of patients without PD or death at 9 months after randomization.
5 secondary outcomes
Objective response rate
Time frame: 6 months
Disease control rate
Time frame: 6 months
Progression free survival
Time frame: up to 3 years
Overall survival
Time frame: up to 4 years
Adverse event rate
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 7 Mar 2024.
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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.
Meng Qiu, M.D. principal investigator
West China Hospital
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 mCapOX plus cetuximab and mFOLFOX6 plus cetuximab in people with Colo-rectal Cancer and Capecitabine, run by West China 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 9 inclusion and 16 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 7 Mar 2024. 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 Xiaofen Li, M.D. (+86-28-85422589, lxf0827@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) rate at 9 months (time frame: 9 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 7 Mar 2024.