Biliary tract cancer (BTC) presents with a 5-year survival rate less than 5%. The goal of this clinical trial is to evaluate if Anlotinib plus Nab-Paclitaxels and S-1 as second-line regimen can improve the treatment efficacy in advanced biliary tract cancer (BTC) after progression upon first-line standard treatment, in comparison with standard second-line FOLFOX regimen.
Signed a written informed consent form before enrollment;
Age >18 years, both male and female are eligible;
Patients with pathologically confirmed advanced biliary tract that has progressed after first-line gemcitabine-based therapy;
Have measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions with a long diameter ≥10 mm on CT scan, or lymph node lesions with a short diameter ≥15 mm on CT scan);
Subjects with a history of or concurrent malignancies, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix;
Known allergy to macromolecular protein preparations or known hypersensitivity to the components of the administered drugs;
Subjects with existing thyroid dysfunction that cannot be maintained within the normal range by medication;
Uncontrolled hypertension despite optimal treatment, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg;
Parallel
Albumin-bound Paclitaxel + Tegafur Gimeracil Oteracil (S-1) + Anlotinib
DrugAlbumin-bound Paclitaxel, 125mg/m2,iv.drip,d1,d8,Q3W +Tegafur Gimeracil Oteracil (S-1) 40-60mg,p.o,bid,d1-d14,Q3W+Anlotinib 10mg,p.o,d1-d14,Q3W
Oxaliplatin + Leucovorin + Fluorouracil (FOLFOX regimen)
DrugOxaliplatin 85 mg/m2,d1,iv.drip,Q2W + Leucovorin 400mg/m2,d1,iv.drip,Q2W+ Fluorouracil 2400 mg/m2 civ46h, Q2W
Overall Survival
Overall Survival (OS), defined as the time between the date of the subject's first dose and the subject's death from all causes. The OS of subjects who were alive at the time of the final follow-up visit was counted as data censored at the time of the final follow-up visit.
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time from the date of the subject's first dose of medication to the date of the first documented tumor progression (assessed according toRECIST 1.1 criteria, with or without continuation of treatment) or the date of death from anycause, whichever occurs first. The median PFS and its 95% Cl will be analyzed using the Kaplan-Meier method and survival graphs will be plotted.
Objective Response Rate
Refers to the proportion of patients whose tumors shrank by a certain amount and remained sofor a certain period of time, and includes both CR and PR cases. Objective tumor remission was assessed using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria).
Disease control rate
Refers to the proportion of patients whose tumors shrank by a certain amount and remained sofor a certain period of time, and includes both CR and PR cases. Obiective tumor remission was assessed using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criterial
Quality of Life
Patients' quality of life was assessed according to the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), assessed at baseline and every 3 weeks thereafter
Adverse Events
Defined as the proportion of grade ≥3 hematologic or non-hematologic toxic events occurring from the start of medication to the end of follow-up. Adverse events include, but are not limited to, liver dysfunction, hematologic system damage, pulmonary toxicity, and ocular toxicity. The severity of adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
CTTQ Pharma
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
