Metastatic Colorectal CancerPhase 2NCT04224415
Re-challenge of Anti-EGFR for Patients With RAS/BRAF Wild-type Metastatic CRC
A Phase 2 study testing C225+CPT-11 in people with Metastatic Colorectal Cancer, run by Yuhong Li at 1 site in China.
Trial summary
The aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- C225+CPT-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2020to 31 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤75.
- Diagnosed as colorectal adenocarcinoma by histology.
- Initially confirmed as RAS/BRAF wild type by tissue molecular detection.
- Treated with first-line therapy of FOLFOX/FOLFIRI/FOLFOXIRI+Cetuximab effectively and the PFS is not less than 6 months.
- Tumor progression during Cetuximab treatment or after treatment within 3 months.
- Tumor progression again after second-line treatment.
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- The interval time of re-challenge is more than 4 months after the last time treated with Cetuximab.
- Lesions can be measured by the standard of RECIST v1.1.
- Defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA,
- No hematologic dysfunction(Platelets >90×10^9/L; WBC >3×10^9/L; Neutrophil >1.5×10^9/L；Hemoglobin >10 g/100ml).
- Serum bilirubin ≤ 1.5 × ULN; aminotransferase ≤ 5 × ULN.
- No ascites; no coagulation dysfunction; albumin ≥ 30g/L.
- Hepatic function was classified as class A by Child-Pugh classification.
- Serum creatinine < 1 × ULN, or creatinine clearance rate(CCR) > 50ml/ min(calculated by Cockcroft-Gault formula).
- ECOG scored as 0-2.
- Life expectancy > 3 months.
- Informed consent.
- Willing and able to receive follow-up until death or trial is finished or trial is terminated.
Who cannot join
- RAS/BRAF mutation.
- Severe arterial embolism or ascites.
- Presence of hemorrhagic tendency or coagulation dysfunction.
- Presence of hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrolled systemic complications, such as infection or diabetes.
- Severe clinical CVD(cardiovascular disease), such as cerebrovascular accident(within 6 months before recruitment), myocardial infarction(within 6 months before recruitment), uncontrolled hypertension; unstable angina pectoris; congestive heart-failure(NYHA 2-4 grade); arrhythmia that needs medication treatment.
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- Previous diagnosed or physical examination showed presence of central nervous system(CNS) disease(i.e. primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastases or stroke).
- Previous history of other malignancy within 5 years(except basal cell carcinoma after radical resection and/or cervical carcinoma in situ).
- Received any medication under research within 28 days before the trial.
- Any residual toxicity of previous chemotherapy(except hair loss), i.e. peripheral neuropathy ≥ NCI CTC v3.0 Grade 2, will be excluded from oxaliplatin-based chemotherapy regimen research pair.
- Allergic to any medication involved in the trial.
- Pregnant and lactating women.
- Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility.
- Unable or unwilling to comply with the research plan.
- The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-challenge of Anti-EGFR Agents for Chinese Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer
The aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer.
Read the detailed description
After first-line treatment of FOLFOX/FOLFIRI/FOLFOXIRI plus Cetuximab failure and defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA, the patients will be treated with Cetuximab and Irinotecan as a second-line or third-line treatment.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- C225+CPT-11
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C225+CPT-11Drug
Patients will receive Systemic C225+CPT-11 every 14 days:
C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1
| Study group | Role | What they receive |
|---|---|---|
| C225+CPT-11 | Other | Patients will receive Systemic C225+CPT-11 every 14 days:
C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1 Receives: Drug: C225+CPT-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
defined as complete remission rates and partial remission rates after treatment.
Measured: Up to 2-4 months
Secondary outcomes (3)
Progress-free Survival(PFS)
defined as the period from the date of receiving treatment to disease progress caused by any reason.
Measured: Up to 2-4 months
Overall Survival(OS)
defined as the period from the date of receiving treatment to death caused by any reason.
Measured: Up to 12 months
Adverse events(AE) and severe adverse events(SAE)
defined as the incidence and severity of adverse events related to chemotherapy
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start31 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224415
- Sponsor's protocol ID
- Anti-EGFR Re-challenge
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2020
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang DS, Chen WC, Ren C, Wang FH, Wang ZQ, Luo HY, Wang F, Tan Q, Li YH. Circulating tumour DNA to guide rechallenge with cetuximab plus irinotecan in RAS/BRAF wild-type metastatic colorectal cancer: A nonrandomised clinical trial. Clin Transl Med. 2026 Sep;16(9):e70827. doi: 10.1002/ctm2.70827.
PubMed 42723578
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-challenge of Anti-EGFR Agents for Chinese Patients With RAS/BRAF Wild-type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04224415
- Acronym / sponsor ID
- Anti-EGFR Re-challenge
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yuhong LiUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Jan 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 aim of the trial is to study the efficacy and safety of Cetuximab re-challenge for Chinese Patients with RAS/BRAF wild-type Metastatic Colorectal Cancer.
Detailed description
After first-line treatment of FOLFOX/FOLFIRI/FOLFOXIRI plus Cetuximab failure and defined as RAS/BRAF wild-type by molecular detection of cycle tumor DNA, the patients will be treated with Cetuximab and Irinotecan as a second-line or third-line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C225+CPT-11 | Other | Drug: C225+CPT-11Patients will receive Systemic C225+CPT-11 every 14 days: C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 and ≤75.
- Diagnosed as colorectal adenocarcinoma by histology.
- Initially confirmed as RAS/BRAF wild type by tissue molecular detection.
- Treated with first-line therapy of FOLFOX/FOLFIRI/FOLFOXIRI+Cetuximab effectively and the PFS is not less than 6 months.
- Tumor progression during Cetuximab treatment or after treatment within 3 months.
Key exclusion criteria (15 listed)
- RAS/BRAF mutation.
- Severe arterial embolism or ascites.
- Presence of hemorrhagic tendency or coagulation dysfunction.
- Presence of hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrolled systemic complications, such as infection or diabetes.
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 |
|---|---|---|
| C225+CPT-11Patients will receive Systemic C225+CPT-11 every 14 days: C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1 | Drug | C225+CPT-11 |
Primary outcome
Objective Response Rate
Time frame: Up to 2-4 months
defined as complete remission rates and partial remission rates after treatment.
3 secondary outcomes
Progress-free Survival(PFS)
Time frame: Up to 2-4 months
Overall Survival(OS)
Time frame: Up to 12 months
Adverse events(AE) and severe adverse events(SAE)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 42723578Wang DS, Chen WC, Ren C, Wang FH, Wang ZQ, Luo HY, Wang F, Tan Q, Li YH. Circulating tumour DNA to guide rechallenge with cetuximab plus irinotecan in RAS/BRAF wild-type metastatic colorectal cancer: A nonrandomised clinical trial. Clin Transl Med. 2026 Sep;16(9):e70827. doi: 10.1002/ctm2.70827.
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CRC
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.
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 C225+CPT-11 in people with Metastatic Colorectal Cancer, run by Yuhong Li 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 18 inclusion and 15 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: finished, as of the sponsor's last update on 15 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate (time frame: Up to 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224415, which also lists 1 linked publication.
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 Feb 2023.