Status:
UNKNOWN
Paclitaxel (Albumin-bound) and Oxaliplatin for Advanced Hepatobiliary and Malignant Tumors
Lead Sponsor:
Dong Wang
Conditions:
Advanced Hepatobiliary and Malignant Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
1\. Advantages of albumin-bound paclitaxel Paclitaxel for injection (albumin-binding type) uses human serum albumin (HAS) as a carrier, and paclitaxel and HSA are made into paclitaxel-bound albumin na...
Eligibility Criteria
Inclusion
- 1\) Patients are ≥ 18 years old; 2) Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination; 3) Having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria; 4) Estimated survival time \> 3 months; 5) There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history; 6) ECOG PS score ≤ 2 points; 7) Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%; 8) Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment; 9) Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min; 10) Patients can understand and sign the informed consent form.
Exclusion
- 1\) Pregnant or lactating female patients (women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose, if they are positive, ultrasound examination is required to be performed to exclude pregnancy); women of childbearing age refuse to receive contraception.
- 2\) Having other malignant tumors, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ carcinoma in any other regions; 3) Having abnormal bone marrow hyperplasia and other hematopoietic disorders; 4) Having active infections, HIV infection, and viral hepatitis that require systemic treatment; 5) Child-Pugh score \> 7 points; 6) Being combined with medium-large ascites or hepatic encephalopathy; 7) Subjects with ≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0; 8)Patients with severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs intervention; 9) Being allergic to the drug or drug ingredients used in this test or having hypersensitivity history; 10) Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 11) Having dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 12) Being considered to be unsuitable for enrollment by investigators.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04060472
Start Date
August 20 2019
End Date
October 20 2023
Last Update
August 19 2019
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