Liver Metastases of Colorectal CancerPhase 2NCT06490913
Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes
A Phase 2 study testing Capecitabine, oxaliplatin and Cetuximab in people with Liver Metastases of Colorectal Cancer, run by Fujian Cancer Hospital.
Trial summary
The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Metastases of Colorectal Cancer
- What is being tested?
- Capecitabine, oxaliplatin and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years (including 18 and 75 years);
- ECOG PS 0 or 1;
- Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;
- Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;
- At least one measurable lesion as defined in RECIST version 1.1;
- Fertile patients must be willing to take highly effective pregnancy avoidance measures during the study period and ≥120 days after the last dosing; Female patients with negative urine or serum pregnancy test results within ≤7 days before the first administration of the study drug;
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- Have fully understood the study and voluntarily signed the informed consent.
- Adequate organ and bone marrow function, meeting the following definitions:
- Blood routine (no transfusion, no use of granulocyte colony stimulating factor [G-CSF], no use of other drugs for correction within 14 days before treatment); Absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥9.0 g/dL; Platelet count (PLT) ≥80×109/L;
- Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min; Serum albumin ≥2.8g/dL. Patients with poor nutritional status before neoadjuvant therapy could also be enrolled if they met the criteria through parenteral nutrition. Total bilirubin (TBIL) ≤ 1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
Who cannot join
- Pregnant or lactating women;
- Patients with a known history of allergy to any investigative drug, similar drug, or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- Patients with a history of thromboembolism, except thrombosis caused by PICC;
- There are patients with active infection;
- Patients with difficult to control hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg);
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- Patients with brain metastases with clinical symptoms or imaging evidence;
- Treatment contraindications exist in combination with other chronic diseases;
- Patients with previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis and other conditions, and the current AE is still ≥ grade 2;
- According to NCI CTCAE version 5.0 evaluation criteria, existing patients with various toxic and side effects caused by previous treatment ≥ grade 2;
- Other conditions that the investigator determined were not suitable for inclusion in the study.
- Received any anti-tumor therapy and participated in other clinical studies within 4 weeks before enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes：a Phase II Single-arm Study
The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.
- Conditions
- Liver Metastases of Colorectal Cancer
- Being tested
- Capecitabine, oxaliplatin, Cetuximab, Leucovorin, 5-FU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
1000mg/m2, bid, d1-d14，q3w，1cycle
oxaliplatinDrug
130mg/m2, ivgtt, d1，q3w，1cycle
CetuximabDrug
cetuximab 500mg/m2, q2w
OxaliplatinDrug
85mg/m2, d1,q2w
LeucovorinDrug
400mg/m2, d1,q2w
5-FUDrug
400mg/m2，d1,q2w
| Study group | Role | What they receive |
|---|---|---|
| cetuximab+chemotherapy | Experimental | XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles Receives: Drug: Capecitabine; Drug: oxaliplatin; Drug: Cetuximab; Drug: Leucovorin; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: every 2 weeks
Secondary outcomes (1)
overall survival
Measured: Around 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastases of Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490913
- Sponsor's protocol ID
- CRC-01
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes：a Phase II Single-arm Study
- ClinicalTrials.gov ID
- NCT06490913
- Acronym / sponsor ID
- CRC-01
- Conditions
- Liver Metastases of Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jul 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.
The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cetuximab+chemotherapy | Experimental | Drug: Capecitabine, Drug: oxaliplatin, Drug: Cetuximab, Drug: Leucovorin, Drug: 5-FUXELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-75 years (including 18 and 75 years);
- ECOG PS 0 or 1;
- Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;
- Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;
- At least one measurable lesion as defined in RECIST version 1.1;
Key exclusion criteria (12 listed)
- Pregnant or lactating women;
- Patients with a known history of allergy to any investigative drug, similar drug, or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- Patients with a history of thromboembolism, except thrombosis caused by PICC;
- There are patients with active infection;
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 |
|---|---|---|
| Capecitabine1000mg/m2, bid, d1-d14，q3w，1cycle | Drug | cetuximab+chemotherapy |
| oxaliplatin130mg/m2, ivgtt, d1，q3w，1cycle | Drug | cetuximab+chemotherapy |
| Cetuximabcetuximab 500mg/m2, q2w | Drug | cetuximab+chemotherapy |
| Oxaliplatin85mg/m2, d1,q2w | Drug | cetuximab+chemotherapy |
| Leucovorin400mg/m2, d1,q2w | Drug | cetuximab+chemotherapy |
| 5-FU400mg/m2，d1,q2w | Drug | cetuximab+chemotherapy |
Primary outcome
Objective Response Rate
Time frame: every 2 weeks
1 secondary outcome
overall survival
Time frame: Around 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, oxaliplatin and Cetuximab in people with Liver Metastases of Colorectal Cancer, run by Fujian Cancer Hospital.
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 10 inclusion and 12 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 8 Jul 2024. 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 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 Li hui, bachelor (13600855801 ext. 86, Lihui7701@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: every 2 weeks). 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 8 Jul 2024.