Clinical trial · Interventional
Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Biliary Tract Cancers | Malignant Biliary Tract Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin and nab-paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel and Cisplatin
- description
- cisplatin and nab-paclitaxel: Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.
- interventionNames
- Drug: cisplatin and nab-paclitaxel
Primary outcomes (1)
- measure
- Objective Response Rate [ORR]
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Progression Free Survival [PFS]
- timeFrame
- 2 years
- measure
- Overall survival [OS]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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