Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer
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|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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885219
|Contact: TaiPing Zhang||13520132976||Tpingzhang@yahoo.com|
|Contact: YueJuan Chengemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China|
|Contact: YueJuan Cheng 861069158315 firstname.lastname@example.org|