Status:
UNKNOWN
A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )
Lead Sponsor:
Yanqiao Zhang
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Voluntarily participate in the trial and sign the informed consent form
- 18 years old \<age \<75 years old
- Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria
- ECOG score 0-1
- Life expectancy \> 3 months
- There must be a CT or MRI examination within a week
- at least one lesion that can be measured by the RECIST v1.1 standard
- No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months)
- without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)
Exclusion
- pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures;
- Severe active infections requiring intravenous antibiotic treatment during enrollment;
- those who are allergic to the test drug;
- There is ≥2 neuropathy (CTCAE 4.0);
- uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction;
- Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
- 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;
- Patients who are unable to follow the protocol or who are unable to follow up;
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03825328
Start Date
January 30 2019
End Date
December 30 2020
Last Update
January 31 2019
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