Pancreatic ductal adenocarcinoma
Conditions
Interventions
Experimental group:All subjects received an intravenous infusion of JJH201601 liposomes at 125 mg/m^2 once every 3 weeks, with a 21-day cycle, until disease progression, intolerable toxicity, the subj
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years old (inclusive); 2. Body Mass Index (BMI) >=17.0 [BMI = weight (kg) / height^2 (m^2)]; 3. Diagnosed by imaging, histology, and/or cytology with unresectable locally advanced or recurrent/metastatic pancreatic ductal adenocarcinoma, biliary tract cancer, or hepatocellular carcinoma, with specific population requirements as follows: (1) Pancreatic ductal adenocarcinoma: Locally advanced or metastatic pancreatic ductal adenocarcinoma that has previously received at least second-line standard treatment with disease progression or intolerance; (2) Biliary tract cancer: Including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder cancer, which has previously received at least first-line standard treatment with disease progression or intolerance; (3) Hepatocellular carcinoma: Barcelona Clinic Liver Cancer (BCLC) stage B or C, liver function Child-Pugh grade A/B (3 months; 5. At least one measurable tumor lesion according to RECIST v1.1 (tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not considered measurable lesions unless the lesion shows clear progression or persists three months after radiotherapy); 6. Performance status score (Eastern Cooperative Oncology Group [ECOG PS] scoring system) 0~1; 7. No prior use of taxane drugs or the last use of taxane drugs was more than 6 months before the first study treatment; 8. Laboratory tests must meet the following criteria: (1) Complete blood count (no transfusion within 28 days or no colony-stimulating factors and erythropoietin within 14 days; no thrombopoietin [TPO] or interleukin-11 within 14 days): absolute neutrophil count (ANC) >= 1.5 × 10^9/L; hemoglobin (HB) >= 90 g/L; platelets (PLT) >= 80 × 10^9/L; (2) Blood biochemistry: albumin (ALB) >= 29.0 g/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50 mL/min (calculated by Cockcroft-Gault); (3) Coagulation function: activated partial thromboplastin time (APTT) = 2 and 24-hour urine protein <= 1.0 g; 9. All subjects and their partners must have no plans for pregnancy from screening until 6 months after the last dose and agree to use effective non-drug contraception methods during the trial (such as abstinence, condoms, non-medicated intrauterine devices, etc.), except those who have undergone permanent contraception such as bilateral tubal ligation or vasectomy; women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment; 10. Voluntarily participate in the clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Specific tumor exclusion criteria: (1) Cohort of pancreatic ductal adenocarcinoma: diagnosed with other pathological types such as acinar cell carcinoma, neuroendocrine carcinoma, pancreatoblastoma, etc.; (2) Cohort of biliary cancer: diagnosed with ampullary carcinoma; (3) Cohort of hepatocellular carcinoma: diagnosed with fibrolamellar hepatocellular carcinoma or sarcomatoid hepatocellular carcinoma; diffuse liver cancer with tumor involving 70% or more of the liver; Budd-Chiari syndrome; tendency for portal hypertension-related bleeding; tumor involvement of the main portal vein Vp4 (entry is allowed if branches on the opposite side of the lesion are patent), the inferior vena cava, or the heart; history of liver transplantation, or currently a candidate for liver transplantation; 2. History of severe allergy to taxane drugs (NCI-CTCAE v5.0 grade >=3); 3. Uncontrolled symptomatic central nervous system metastases (excluding asymptomatic or stable disease for more than 4 weeks, with the patient not requiring steroids or anti-convulsants for at least 4 weeks prior to treatment initiation and no significant peritumoral edema on imaging); presence of meningeal metastases, spinal cord metastases, or brainstem metastases; 4. Subjects with partial or complete intestinal obstruction, or complete biliary obstruction that cannot be relieved despite active treatment; 5. Received chemotherapy, radiotherapy (local bone radiotherapy acceptable within 2 weeks), biologic therapy, immunotherapy, or other anti-tumor treatments within 4 weeks prior to first dose; received fluoropyrimidines, small molecule targeted drugs, or Chinese patent medicines with anti-tumor indications within 2 weeks prior to first dose; received cell therapy within 3 months prior to first dose; received other investigational drugs not yet marketed within 4 weeks prior to first dose; 6. Occurrence of other malignant tumors within 5 years prior to enrollment, except for cured cervical carcinoma in situ, cutaneous squamous cell carcinoma, basal cell carcinoma, or papillary thyroid carcinoma; 7. Presence of moderate or greater pleural effusion, ascites, or pericardial effusion requiring repeated drainage prior to screening; 8. Severe cardiovascular diseases, including but not limited to: (1) Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second- to third-degree atrioventricular block; (2) Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to first drug administration; (3) New York Heart Association (NYHA) functional class >= II or left ventricular ejection fraction (LVEF) 450 ms for men or > 470 ms for women on a 12-lead electrocardiogram (ECG) (calculated using the Fridericia formula: QTcF = QT/(RR^0.33)); (5) Clinically uncontrolled hypertension (systolic = 150 mmHg and/or diastolic = 100 mmHg after intervention); 9. Active hepatitis B [if HBsAg positive, HBV-DNA must be < 500 IU/ml or 10^3 copies (for hepatocellular carcinoma patients, HBV-DNA must be < 2000 IU/ml or 10^4 copies), and the patient must agree to take antiviral drugs (such as entecavir, adefovir dipivoxil, tenofovir disoproxil, tenofovir alafenamide) throughout the study; effective anti-HBV therapy is allowed for enrollment]; active hepatitis C (patien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of AE and SAE;Progression-Free Survival;Duration of Response;Disease Control Rate;Overall Survival;6-month survival rate;12-month survival rate; | — |
Countries
China
Contacts
Public ContactLi Xiangcheng
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed