Biliary Tract Carcinomas
Conditions
Interventions
treatment group:nab-paclitaxel plus S-1 and anlotinib
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically (histologically or cytologically) verified inoperable or recurrent or metastatic biliary tract carcinoma, including gallbladder carcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma. 2. No systemic therapy after diagnosed as metastatic cholangiocarcinoma. For patients who received adjuvant therapy, previous adjuvant therapy must be completed at least 6 months prior to inception. 3. At least one measurable lesion according to RECIST1.1. 4. Age 18 to 70 years old. 5. ECOG PS 0 TO 1. 6. Life expectancy >= 3 months. 7. Adequate bone marrow function, defined as neutrophils >=1.5x10^9/L, hemoglobin >= 90g/L, thrombocyte >= 100x10^9/ L. 8. Adequate hepatic function, defined as AST and ALT <= 2.0 x ULN, total bilirubin <=1.5 x ULN. 9. Adequate coagulation function, defined as PT and INR <=1.5 x ULN. 10. Adequate renal function, defined as serum creatinine <= 1.5 x ULN. 11. Serum calcium <= 12 mg/dL. 12. Woman of childbearing age must have a negative pregnancy test, and must be willing to consent to using effective contraception during treatment. 13. Capability of received oral medication. 14. Willingness to offer tissue sample for IHC and NGS detection, and willingness to offer blood sample prior to and post treatment. 15. Willingness to receive long-term follow up. 16. Ability to understand and willingness to sign a written informed consent document prior to the enrollment of the trial.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically verified pathological subtype as non-adenocarcinoma or squamous cell carcinoma. 2. Previous administration of nab-paclitaxel or anlotinib capsule. 3. Evidence of another primary cancer within 5 years or currently that may impair patients outcome as determined by the Principal Investigator (PI),except for in-situ carcinoma of the cervix treated curatively, non-melanoma skin carcinoma, and treated superficial bladder carcinoma (Ta(non-invasive carcinoma), Tis(in situ carcinoma), and T1 (tumor infiltrating basilar membrane)). 4. Unrelieved toxicity more serious than grade 1 (CTCAE 5.0) induced by previous therapy, not including alopecia and grade 1 to 2 neurotoxicity induced by oxaliplatin. 5. Any condition that influences the effect of oral medication (disability of swallowing whole pills, chronic diarrhea and so on). 6. Propensity of gastrointestinal hemorrhage, including (1) patients with locally active peptic ulcer, accompanied with OB 2+;(2) patients experienced melena or hematemesis within 2 months; (3) other conditions that determined by principal investigator as high risks of massive gastrointestinal hemorrhage. 7. Radiographically, tumor has infiltrated the great vessels or has the propensity to infiltrate the great vessel as disease progress lately determined by the principal investigator, which indicating a high risk of massive hemorrhage 8. Embolism of artery of vein within 6 months, including cerebrovascular accidence, deep vein embolism, pulmonary embolism and so on. 9. Congestive heart failure (New York Heart Association Class II or higher). 10. History of myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, and uncontrolled arrythmia. 11. Uncontrolled concomitant diseases that would limit the medication according to the study requirements. 12. Participation of other anti-neoplasm clinical trials under way or within 4 weeks prior to inception. 13. Known or suspected allergy to nab-paclitaxel, S-1 or anlotinib. 14. Psychiatric medication abuse or psychiatric illness that would limit the compliance with the study requirement 15. Known poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;objective response rate;disease control rate;disease control rate;duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactChunxia Du
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Outcome results
None listed