Advanced or Metastatic Cholangiocarcinoma

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Dec 9, 2022

Keywords

ClinConnect Summary

Cholangiocarcinoma (CCA) is a cancer that easily invades adjacent structures. Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR2) are increased in most types of cancer and inhibit tumor progression by blocking VEGF/VEGFR2 \[16\]. Apatinib is a highly selective VEGFR2 antagonist that inhibits apoptosis and growth of CCA cells. Apatinib is also a derivative of PTK787, and its targets include VEGFR-1, VEGFR-2, PDGFR, c-kit, c-Src, etc. The activity of Apatinib against VEGFR-2 is 137 times that of PTK787, the IC50 is only 1nmol/L, and it can strongly inhibit tumor angiogenesi...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma;
• • 2. Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel;
• • 3. Age ≥18 years old and under 75 years old;
• • 4. Predicted survival ≥3 months;
• • 5. ECOG score 0-1;
• • 6. Child-Pugh score\<8
• • 7. There was at least one measurable tumor lesion with a long diameter ≥10 mm and a short diameter ≥15 mm on spiral CT. For general CT or physical examination, the maximum diameter must be ≥20mm;
• • 8. The results of liver and kidney function and blood routine examination within 1 week before enrollment were consistent with the following conditions， ANC≥1.5×10\^9/L,PLT≥80×10\^9/L,HGB≥80g/L,Cr≤1.5×ULN,TBIL≤2.5×ULN,ALP≤2.5×ULN,AST≤2.5×ULN,ALT≤2.5×ULN
• • 9. Patients participate voluntarily and sign informed consent forms
• Exclusion Criteria:
• • 1. Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel;
• • 2. Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention;
• • 3. Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
• • 4. Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency;
• • 5. History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix);
• • 6. Interstitial pneumonia or pulmonary fibrosis;
• • 7. Uncontrollable pleural effusion or ascites;
• • 8. Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months);
• • 9. Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study;
• • 10. The researchers determined that the patients were not suitable for this study.

Trial Officials