Colorectal cancer
Conditions
Interventions
Experimental group:Furquitin + Cetuximab ß
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Have been fully informed about the study and have voluntarily signed a written informed consent form; 2.Aged 18–75 years (inclusive); 3.Histologically confirmed advanced metastatic colorectal adenocarcinoma; 4.Tumor tissue genotyping demonstrating wild-type NRAS, KRAS, and BRAF; 5.Have previously received first-line oxaliplatin- and irinotecan-based therapy, or have received at least two lines of standard chemotherapy and experienced treatment failure. These standard regimens must have included fluoropyrimidines, oxaliplatin, and irinotecan, with or without bevacizumab or cetuximab. Treatment failure is defined as disease progression during treatment or within 3 months after the last dose, or unacceptable toxicity. Each line of therapy must have included at least one cycle of one or more chemotherapeutic agents. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, such therapy will be considered a failure of first-line chemotherapy for advanced disease; 6.At least one measurable lesion according to RECIST version 1.1; 7.ECOG performance status of 0–1; 8. Expected survival time >= 12 weeks; 9. Within 7 days before enrollment, the function of major organs must meet the following requirements (the use of any blood components and growth factors is not allowed within 14 days before enrollment): (1) Absolute neutrophil count >= 1.5 × 10^9/L; (2) Platelets >= 80 × 10^9/L; (3) Hemoglobin >= 8 g/dL; (4) Total bilirubin = 50 ml/min; (7) International Normalized Ratio (INR) <= 1.5 or Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN; 10.Good compliance and willingness to cooperate with follow-up;
Exclusion criteria
Exclusion criteria: 1. Unable to comply with the research protocol or research procedures; 2. Previous treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKI); 3. Participated in another drug clinical trial within the past 4 weeks; 4. Received or currently receiving other systemic antitumor therapy within 4 weeks prior to enrollment; 5. The patient currently has uncontrolled hypertension that is defined as: systolic pressure > 140 mmHg and/or diastolic pressure > 90 mmHg; 6. The patient currently has any disease or condition that affects drug absorption, or the patient is unable to take oral medications; 7. The patient currently has active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases, or the presence of active bleeding from an unremoved tumor, or other conditions that the investigator deems may cause gastrointestinal bleeding or perforation; 8. History of arterial thrombosis or deep vein thrombosis within the past 6 months; 9. Patients with evidence or history of significant bleeding tendency within the past 2 months, such as black stools, hematemesis, hemoptysis, fecal occult blood ++ or above (patients with fecal occult blood + and with primary disease focus must undergo gastroscopy to exclude bleeding or ulcers before being included in the group); 10. Stroke event and/or transient ischemic attack within 12 months prior to enrollment; significant cardiovascular disease with clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) class >2; ventricular arrhythmias requiring medication treatment; LVEF (left ventricular ejection fraction) = 1×10^4 copies/mL or > 2000 IU/mL); 13. Pregnancy (positive pregnancy test before medication) or lactating women; 14. Urinalysis indicating proteinuria >= 2+, or 24-hour urine protein > 1.0 g;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Disease control rate;Progress-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYongkun Sun
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed