Advanced or Metastatic Cholangiocarcinoma

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

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients with advanced or metastatic cholangiocarcinoma, a type of cancer that affects the bile ducts. The study will test a combination of three medications: carralizumab, albumin paclitaxel, and apatinib mesylate, specifically for patients who have already tried other chemotherapy treatments but need a second-line option. The goal is to see how well this combination can help patients live longer without their cancer getting worse.

To participate in this trial, patients need to be between 18 and 75 years old, have a confirmed diagnosis of unresectable or metastatic cholangiocarcinoma, and have previously received treatment with chemotherapy, like gemcitabine. Participants will take the new medications and will be monitored every two cycles to check how well the treatment is working and if they can tolerate it. It's important to note that patients must not have certain medical conditions that could make the treatment unsafe. This trial is currently not yet recruiting participants, but it offers a potential new option for those who qualify.

Gender

ALL

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.