liver metastases of colorectal cancer
Conditions
Interventions
test group:Drugs based on organoid drug screening results
control group:Standard second-line drugs
Sponsors
Shandong First Medical University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients had to meet all of the following criteria: 1. The subjects voluntarily participated in the study, signed the informed consent form, and the compliance was good. 2. Male or female, aged 18 years or above, clinically able to tolerate 2 or more cycles of chemotherapy; 3. ECOG score of 0-1; 4. Expected survival time >= 6 months; 5. Patients with pathologically confirmed liver metastases from colorectal adenocarcinoma; 6. No previous systemic therapy, including chemotherapy, targeted therapy and immunotherapy; Note: Patients relapsed more than 6 months after neoadjuvant chemoradiotherapy plus radical surgery, or relapsed more than 6 months after adjuvant chemoradiotherapy or radical concurrent chemoradiotherapy. 7. Sufficient surgical or biopsy tissue can be obtained from primary and metastatic lesions; 8. The subject has recovered from the damage caused by other treatments, including other cytotoxic drugs, radiotherapy or surgery for >= 4 weeks, and the wound has completely healed; 9. Asymptomatic brain metastases or control of brain metastases after radiotherapy; 10. The main organ function is normal, and the subject must meet the following laboratory indicators: 1) absolute neutrophil count (ANC) >=1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days; 2) platelet count >=90×10^9/L without blood transfusion in the past 14 days; 3) hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days; 4) no active bleeding, such as hematemesis, hematochezia, gums bleeding, epistaxis and hemorrhoids bleeding, and fecal occult blood =60 ml/min; 8) good coagulation function, defined as INR or PT <=1.5 times ULN; Activated partial thromboplastin time (APTT) <=1.5×ULN; (For patients who are receiving anticoagulant therapy, such as aspirin, warfarin, clopidogrel and other drugs, the drug should be stopped for at least 5-7 days in principle, and the INR and APTT are within the safe and effective therapeutic range as judged by the investigator). 9) Euthyroidism, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. 10) myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators as not clinically significant were also allowed); 11. For patients of childbearing potential, use of a medically approved contraceptive method (such as an intrauterine device, contraceptive pill or condom) during the study treatment period and for 1 month after the end of the study treatment period; Patients had to have a negative serum or urine HCG test within 72 hours before study entry, and they had to be non-lactating.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria were not eligible for inclusion in the study: 1. Inability to obtain sufficient tumor tissue through surgery or biopsy; 2. Are currently participating in an interventional clinical study treatment or have received another clinical study within 4 weeks before the first dose; 3. Received Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose; 4. Patients with active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrolled hypertension within 30 days after major surgery, grade III-IV cardiac dysfunction (NYHA criteria), severe liver and kidney dysfunction (grade 4); 5. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade =1 or baseline, excluding fatigue or alopecia); 6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 7. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory at the participating center); Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion: 1) Subjects with HBV viral load = ? degree heart block, ventricular arrhythmia or atrial fibrillation; 2) patients with NYHA class ?-? cardiac dysfunction or left ventricular ejection fraction (LVEF) 2) occurred 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on baseline chest imaging, signs and symptoms of infection within 2 weeks before the first dose of study drug, or the need for oral and intravenous antibiotics. 7) clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; 8) liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 9) patients with a definite GI ble
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;AEs; | — |
Countries
China
Contacts
Public ContactSha Dan
Shandong First Medical University Affiliated Provincial Hospital
Outcome results
None listed