Status:
UNKNOWN
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Pancreatic Cancer
Nab-paclitaxel
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
Detailed Description
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of pancreatic adenocarcinoma
- Distant metastatic or unresctable locally advanced diseases
- CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
- At least one lesion measurable by RECIST v1.1 criteria
- Life expectancy\> 3 months
- No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
- No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
- Pain must be monitored before inclusion
- 18 years \< age \< 70
- Performance status: 0-1
- ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
- ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
- Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
- creatinine \< 120 μmol/L, or MDRD creatinine clearance \> 60 mL/min
- Patient information and signature of informed consent
Exclusion
- Concurrent other effective treatment (including radiotherapy)
- Resectable patients
- Allergy history to other drugs in the same class patients with pregnancy or lactation
- Known severe internal medical diseases
- Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
- Immunocompromised patients, such as HIV positive
- Uncontrollable mental illness
- Other conditions the researchers considered ineligible for the study
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03779464
Start Date
August 1 2019
End Date
September 30 2021
Last Update
July 8 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022