Colorectal Cancer (CRC)Phase 3CAPCET-IIINCT06616259
First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study
A Phase 3 study testing mCapOX plus Cetuximab and mFOLFOX6 plus Cetuximab in people with Colorectal Cancer (CRC) and Capecitabine, run by Meng Qiu at 1 site in China.
Trial summary
This multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS/BRAF wild-type, MSS, Unresectable Left-Sided mCRC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC), 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
- 452 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2024to 30 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 RAS and BRAF wild-type, MSS/pMMR, metastatic left-sided colorectal adenocarcinoma.
- Presence of at least one evaluable lesion, as defined in RECIST Version 1.1.
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy.
- 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.) .
- Requirements for lab indicators: neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 75 × 10^9/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. Contact the study team or a site near you to ask about taking part.
Meng Qiu, M.D. contact
China1 site
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
Yuwen Zhou, M.D., +028 15328007741, drzhouyuwen@163.com
Meng Qiu, M.D.
About this study
Official title: First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided Metastatic Colorectal Cancer: a Multicenter, Randomized, Controlled, Phase III Study
This multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS/BRAF wild-type, MSS, Unresectable Left-Sided mCRC.
Read the detailed description
Study participants who meet the enrollment criteria will be randomly assigned in a 1:1 ratio to either the mCapOX + cetuximab or mFOLFOX6 + cetuximab treatment groups, and those who have achieved control of their disease (Complete response [CR] + Partial response [PR] + Stable disease [SD]) after a maximum of 12 cycles of first-line induction therapy in both groups will continue to receive Capecitabine or Capecitabine + Cetuximab maintenance therapy until disease progression or toxicity is not tolerated or informed consent is withdrawn.
- Conditions
- Colorectal Cancer (CRC), Capecitabine, Cetuximab
- Being tested
- mCapOX plus Cetuximab, mFOLFOX6 plus Cetuximab
- Keywords
- CAPCET-III
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCapOX plus CetuximabDrug
mCapOX plus Cetuximab Induction therapy：Capecitabine 1000mg/m2 po, bid, D1-7 + Oxaliplatin ivgtt 85mg/m2, D1 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Up to 12 cycle, if no progression, enter maintenance therapy.
Maintenance therapy: Capecitabine 1000mg/m2 po, bid, D1-7 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Until disease progression or toxicity is not tolerated. Cetuximab can be discontinued alone if not tolerated.
Treatment after progression of maintenance therapy: Participants have the option to accept reintroducing the first-line induction chemotherapy regimen (mCapOx or mFOLFOX6 in combination with cetuximab) or accept second-line therapy.
mFOLFOX6 plus CetuximabDrug
mFOLFOX6 plus Cetuximab Induction therapy：Oxaliplatin ivgtt 85mg/m2, D1 + Leucovorin ivgtt 400mg/m2, D1 + Fluorouracil iv bolus 400mg/m2, D1 + Fluorouracil 2400mg/m2 continuous infusion for 46-48h + Cetuximab ivgtt 500mg/m2, D1; Q2W. Up to 12 cycle, if no progression, enter maintenance therapy.
Maintenance therapy: Capecitabine 1000mg/m2 po, bid, D1-7 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Until disease progression or toxicity is not tolerated. Cetuximab can be discontinued alone if not tolerated.
Treatment after progression of maintenance therapy: Participants have the option to accept reintroducing the first-line induction chemotherapy regimen (mCapOx or mFOLFOX6 in combination with cetuximab) or accept second-line therapy.
| 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)
Progression free survival is defined as the period from randomization to disease progress or death. Includes first-line induction therapy and maintenance therapy.
Measured: up to 3 years
Secondary outcomes (7)
Objective Response Rate (ORR)
Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) during treatment. Based on RECIST 1.1.
Measured: 6 months
Disease control rate (DCR)
Defined as the proportion of patients who acquired Complete response (CR), Partial response (PR), or Stable disease (SD) during treatment. Based on RECIST 1.1.
Measured: 6 months
Time to Failure of Strategy (TFS)
Defined as the time from the date of randomization to [secondary disease progression after reintroduction of first-line induction chemotherapy following maintenance therapy disease progression] or [all-cause death].
If participants progressed on maintenance therapy after first-line induction chemotherapy without reintroduction of first-line induction chemotherapy or progressed during first-line induction chemotherapy, TFS equals PFS
Measured: up to 3 years
Overall Survival (OS)
Defined as the period from randomization to death from any cause
Measured: up to 5 years
Adverse Event rate
The rate of adverse event after treatment
Measured: up to 3 years
Pharmacoeconomic
Including CERs (Cost-Effectiveness Ratios) and ICERs (Incremental Cost-Effectiveness Ratios).
CERs：Defined as the ratio of the total costs of a medical intervention to the health benefits gained from that intervention.
ICERs：Defined as the ratio of the difference in costs between two alternative interventions（Arm A and Arm B） to the difference in their effectiveness.
Measured: up to 3 years
Quality of Life
Assessment of quality of life through the Quality of Life Questionnaire (QLQ)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start26 Sep 2024 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- 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
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meng Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meng Qiu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616259
- Sponsor's protocol ID
- 20240716
- Acronym
- CAPCET-III
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RAS/BRAF Wild-type, MSS, Unresectable Left-Sided Metastatic Colorectal Cancer: a Multicenter, Randomized, Controlled, Phase III Study
- ClinicalTrials.gov ID
- NCT06616259
- Acronym / sponsor ID
- CAPCET-III / 20240716
- Conditions
- Colorectal Cancer (CRC), Capecitabine, Cetuximab
- Keywords
- CAPCET-III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Meng QiuUniversity, hospital or other
- Study start
- 26 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Sep 2024 (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 multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS/BRAF wild-type, MSS, Unresectable Left-Sided mCRC.
Detailed description
Study participants who meet the enrollment criteria will be randomly assigned in a 1:1 ratio to either the mCapOX + cetuximab or mFOLFOX6 + cetuximab treatment groups, and those who have achieved control of their disease (Complete response [CR] + Partial response [PR] + Stable disease [SD]) after a maximum of 12 cycles of first-line induction therapy in both groups will continue to receive Capecitabine or Capecitabine + Cetuximab maintenance therapy until disease progression or toxicity is not tolerated or informed consent is withdrawn.
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 (8 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 RAS and BRAF wild-type, MSS/pMMR, metastatic left-sided colorectal adenocarcinoma.
- Presence of at least one evaluable lesion, as defined in RECIST Version 1.1.
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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 CetuximabmCapOX plus Cetuximab Induction therapy：Capecitabine 1000mg/m2 po, bid, D1-7 + Oxaliplatin ivgtt 85mg/m2, D1 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Up to 12 cycle, if no progression, enter maintenance therapy. Maintenance therapy: Capecitabine 1000mg/m2 po, bid, D1-7 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Until disease progression or toxicity is not tolerated. Cetuximab can be discontinued alone if not tolerated. Treatment after progression of maintenance therapy: Participants have the option to accept reintroducing the first-line induction chemotherapy regimen (mCapOx or mFOLFOX6 in combination with cetuximab) or accept second-line therapy. | Drug | Arm A |
| mFOLFOX6 plus CetuximabmFOLFOX6 plus Cetuximab Induction therapy：Oxaliplatin ivgtt 85mg/m2, D1 + Leucovorin ivgtt 400mg/m2, D1 + Fluorouracil iv bolus 400mg/m2, D1 + Fluorouracil 2400mg/m2 continuous infusion for 46-48h + Cetuximab ivgtt 500mg/m2, D1; Q2W. Up to 12 cycle, if no progression, enter maintenance therapy. Maintenance therapy: Capecitabine 1000mg/m2 po, bid, D1-7 + Cetuximab ivgtt 500mg/m2, D1; Q2W. Until disease progression or toxicity is not tolerated. Cetuximab can be discontinued alone if not tolerated. Treatment after progression of maintenance therapy: Participants have the option to accept reintroducing the first-line induction chemotherapy regimen (mCapOx or mFOLFOX6 in combination with cetuximab) or accept second-line therapy. | Drug | Arm B |
Primary outcome
Progression free survival (PFS)
Time frame: up to 3 years
Progression free survival is defined as the period from randomization to disease progress or death. Includes first-line induction therapy and maintenance therapy.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: 6 months
Disease control rate (DCR)
Time frame: 6 months
Time to Failure of Strategy (TFS)
Time frame: up to 3 years
Overall Survival (OS)
Time frame: up to 5 years
Adverse Event rate
Time frame: up to 3 years
Pharmacoeconomic
Time frame: up to 3 years
Quality of Life
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Meng Qiu, M.D. contact
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 mCapOX plus Cetuximab and mFOLFOX6 plus Cetuximab in people with Colorectal Cancer (CRC) and Capecitabine, run by Meng Qiu 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 8 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: opening soon, as of the sponsor's last update on 27 Sep 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuwen Zhou, M.D. (+86 15328007741, drzhouyuwen@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) (time frame: up to 3 years). 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 27 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.