Pancreatic Cancer
Conditions
Brief summary
This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer. This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.
Interventions
DRUGAlbumin-bound paclitaxel
Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
DRUGS-1
a combination preparation of tegafur, gimeracil, and oteracil potassium
DRUGOxaliplatin
The compound features a square planar platinum(II) center. In contrast to cisplatin and carboplatin, oxaliplatin features the bidentate ligand 1,2-diaminocyclohexane in place of the two monodentate ammine ligands. It also features a bidentate oxalate group.
DRUGGemcitabine
Gemcitabine is a synthetic pyrimidine nucleoside prodrug-a nucleoside analog in which the hydrogen atoms on the 2' carbon of deoxycytidine are replaced by fluorine atoms.
Sponsors
Yanqiao Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in the trial and sign the informed consent form 2. 18 years old \<age \<75 years old 3. Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria 4. ECOG score 0-1 5. Life expectancy \> 3 months 6. There must be a CT or MRI examination within a week 7. at least one lesion that can be measured by the RECIST v1.1 standard 8. No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months) 9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)
Exclusion criteria
1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures; 2. Severe active infections requiring intravenous antibiotic treatment during enrollment; 3. those who are allergic to the test drug; 4. There is ≥2 neuropathy (CTCAE 4.0); 5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack; 7. Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled; 8. Patients who are unable to follow the protocol or who are unable to follow up;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from the first drug administration up to 6 months | progression-free survival |
| OS | from the first drug administration up to 1 year | overall survival |
Contacts
Primary ContactZhang Yanqiao, PHD
Backup ContactWang Guangyu, PHD
Outcome results
None listed