Liver Metastases of Colorectal Cancer
Conditions
Brief 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.
Interventions
DRUGCapecitabine
1000mg/m2, bid, d1-d14，q3w，1cycle
DRUGoxaliplatin
130mg/m2, ivgtt, d1，q3w，1cycle
DRUGCetuximab
cetuximab 500mg/m2, q2w
DRUGOxaliplatin
85mg/m2, d1,q2w
DRUGLeucovorin
400mg/m2, d1,q2w
DRUG5-FU
400mg/m2，d1,q2w
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | every 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | Around 2 years |
Contacts
Primary ContactLi hui, bachelor
Outcome results
None listed