To hear about similar clinical trials, please enter your email below
Trial Title:
Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes
NCT ID:
NCT06490913
Condition:
Liver Metastases of Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Leucovorin
Capecitabine
Oxaliplatin
Cetuximab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2, bid, d1-d14，q3w，1cycle
Arm group label:
cetuximab+chemotherapy
Intervention type:
Drug
Intervention name:
oxaliplatin
Description:
130mg/m2, ivgtt, d1，q3w，1cycle
Arm group label:
cetuximab+chemotherapy
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
cetuximab 500mg/m2, q2w
Arm group label:
cetuximab+chemotherapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
85mg/m2, d1,q2w
Arm group label:
cetuximab+chemotherapy
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
400mg/m2, d1,q2w
Arm group label:
cetuximab+chemotherapy
Intervention type:
Drug
Intervention name:
5-FU
Description:
400mg/m2，d1,q2w
Arm group label:
cetuximab+chemotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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;
- Have fully understood the study and voluntarily signed the informed consent.
- Adequate organ and bone marrow function, meeting the following definitions:
1. 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;
2. 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;
Exclusion Criteria:
- 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);
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06490913
