Status:
NOT_YET_RECRUITING
Decision-making of ctDNA in Patients With mCRC After Failure of First-line Treatment Containing Cetuximab - a Single-center, Phase II Clinical Study
Lead Sponsor:
Fudan University
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This study aimis at detecting the genomic changes of ctDNA in patients of RAS and BRAF wild-type mCRC, who failed after first line treatment containing cetuximab. According to the results of ctDNA det...
Eligibility Criteria
Inclusion
- Age ≥18, gender unlimited;
- Proven histologically by colorectal adenocarcinoma, local lesions can not be radical resection or metastatic colorectal cancer;
- Patients with RAS and BRAF wild-type tissue genetic testing, receiving first-line treatment containing cetuximab, and radiographic evaluation of disease progression;
- Eastern Cooperative Oncology Group (ECOG) physical condition score (PS) 0 \~ 2;
- Expected survival of more than 3 months;
- Within 7 days before screening (including 7 days), laboratory test data requirements were as follows: neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L (no blood transfusion within 14 days), serum total bilirubin ≤1.25 times the upper normal limit (ULN);ALT and AST≤ 2.5 x ULN (≤5x ULN in patients with liver metastasis);Serum creatinine ≤1.0 x ULN and creatinine clearance rate ≥60 mL /min;Left ventricular ejection fraction in ultrasound examination \>55%;
- At least one measurable lesion (RECIST 1.1 criteria);
- Subjects (or their legal representative/guardian) must sign the informed consent indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Exclusion
- Those who have one or more of the following will not be included in the study:
- Have received any experimental drugs or anti-tumor drugs within 4 weeks before enrollment;
- A history of other tumors in the past five years, except for cervix cancer or basal cell carcinoma of the skin that has been cured;
- Patients with obvious intracranial hypertension or neuropsychiatric symptoms due to uncontrolled primary brain tumor or central nerve metastatic tumor
- Pregnant or lactating women;Those who are fertile but do not take adequate contraceptive measures;
- Alcoholism or drug addiction;
- with pleural effusion or ascites, causing respiratory syndrome (≥CTCAE2 grade dyspnea), requiring local treatment;
- Patients with the following serious or uncontrolled diseases: severe heart disease, unstable condition after treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment;Definite neuropathy or psychosis, including dementia or seizures;Severe or uncontrolled infections;Patients with active and disseminated intravascular coagulation and significant bleeding tendency
- known hypersensitivity or anaphylaxis to any component of the study drug to be applied.
- The function of important organs is obviously impaired
- Other circumstances under which the investigator considers that the patient should not participate in the study
Key Trial Info
Start Date :
April 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04831528
Start Date
April 10 2021
End Date
June 30 2026
Last Update
April 5 2021
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