Overview

A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )

Status:
Unknown status
Trial end date:
2020-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yanqiao Zhang
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Oxaliplatin
Paclitaxel
Criteria
Inclusion Criteria:

1. Voluntarily participate in the trial and sign the informed consent form

2. 18 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;