Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03885219|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Pancreatic Cancer||Drug: Nab-paclitaxel and S-1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: nab-paclitaxel and S-1
chemotherapy of Nab-Paclitaxel and S-1, repeat 21 days for up to 8 cycles. The following treatment including pancreatectomy, continuing same chemotherapy, S-1 maintenance therapy, or radiotherapy will be decided after discussion between physicians and patients.
Drug: Nab-paclitaxel and S-1
Nab-paclitaxel: 120 mg/m2 d1, 8, S-1:Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 , < 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.
- 6-month progression-free survival (PFS) [ Time Frame: 6 months ]The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.
- Objective Response Rate (ORR) [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ]Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885219
|Contact: TaiPing Zhang||13520132976||Tpingzhang@yahoo.com|
|Contact: YueJuan Chengfirstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China|
|Contact: YueJuan Cheng 861069158315 email@example.com|