Advanced Biliary Tract Cancers Clinical Trial
Official title:
Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers: a Prospective, Open Label, Single-arm Phase II Trial
To verify the role of nab-paclitaxel in second or later-line treatment in advanced biliary tract cancers, the investigators designed a prospective, exploratory, single arm,single center phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as second or later-line treatment in advanced biliary tract cancers.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | September 2023 |
| Est. primary completion date | March 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Age ranges from 18 to 75 years - Radiographically, histologically or/and cytologically diagnosed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. - Received at least one first-line systemic treatment for advanced or metastatic diseases and failed, with imaging evidence of disease progression. - ECOG performance status 0-1 - According to the RECIST1.1 standard, at least one measurable objective lesion should be judged. - Expected survival more than 12 weeks - The laboratory test meet the following requirements: Bone marrow function: neutrophils = 1.5×10(9)/L, platelets = 100×10(9)/L, hemoglobin = 90 g/L Liver function:Total bilirubin = 1.5x ULN;AST and ALT) = 2.5x ULN Renal function:Cr = 1.5x ULN,Ccr = 45 ml/min Coagulation function:INR=1.5×ULN, PT=1.5ULN, APTT within the normal range - Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver). - During the non-lactation period, contraceptive measures should be taken in patients of child-bearing age during this trial. The test ofß- HCG was negative. - The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form Exclusion Criteria: - With Chemotherapy contraindication, known to be allergic, highly sensitive or intolerable to research-related drugs or excipient. - Pregnant or lactating women. - Refuse or fail to sign informed consent to participate in the trial - Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03 - Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP=160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure>NYHA grade II, severe arrhythmia, pericardial effusion, etc. - Patients with severe systemic infections or other serious diseases. - Combined with other primary tumors - Patients not suitable for the group according to the judgement of the researcher, with mental disease. - Patients with symptomatic central nervous system (CNS) metastases who require radiotherapy, surgery or sustained corticosteroid use, and untreated brain metastases that cause any symptoms - Prior exposure to nab-paclitaxel - The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Henan Provincial Hospital | CSPC Ouyi Pharmaceutical Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate [ORR] | 2 years | ||
| Secondary | Progression Free Survival [PFS] | 2 years | ||
| Secondary | Overall survival [OS] | 2 years | ||
| Secondary | Disease Control Rate [DCR] | 2 years | ||
| Secondary | adverse events | 2 years |