recurrent/metastatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Nab-Paclitaxel 150 mg/m2, iv, d1
capecitabine 2g/m2, po, d1-7
Q2W,until disease progression or unacceptable toxicity
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over; 2. Patients with unresectable, recurrent or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma) diagnosed by histopathology or cytology; 3. Patients who have not previously received chemotherapy or who have relapsed at least 6 months after adjuvant chemotherapy withdrawal; 4. Bone marrow function: white blood cells >=3x10^9/L, neutrophils>=1.5x10^9/L, platelets>=100x10^9/L, hemoglobin>=90g/L; 5. Liver and kidney function: AST and ALT<=2.5 ULN; total bilirubin<=1.5 ULN; if due to liver metastasis, the above index<=5 ULN; serum creatinine (Cr)<=1.5 ULN; 6. At least one measurable lesion; 7. ECOG score (0 or 1 ); 8. Expected survival of more than 12 weeks; 9. Any acute, clinically relevant treatment-related toxicity (caused by previous treatment) prior to enrollment must be alleviated to toxicity <=1 (according to CTCAE 5.0), except for hair loss; 10. Patients without biliary obstruction or who require biliary stent implantation must be completed at least 21 days prior to enrollment; 11. The patient signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastases; 2. Patients with weight-bearing bone metastases; 3. Intestinal obstruction or incomplete intestinal obstruction; 4. There are currently uncontrolled infections or systemic antibiotics within 72 hours of receiving chemotherapy; 5. Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction; 6. Patients with previous malignant tumors that have not been cured or have brain metastases; 7. Those who are allergic to chemotherapy drugs in this study; 8. Suffering from mental or neurological disorders that cannot be matched; 9. Female patients during pregnancy or lactation; women of childbearing age who refuse to receive contraception; 10. Patients with other diseases that are not suitable for inclusion, such as active tuberculosis, active pneumonia, uncorrectable electrolyte imbalance, uncontrollable tumor-related pain, uncontrollable pleural effusion, and ascites; 11. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactShen Lin
Beijing Cancer Hospital
Outcome results
None listed