Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Provincial Hospital; Henan Provincial People's Hospital
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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 ofβ- 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.