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
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Condition or disease | Intervention/treatment | Phase |
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Locally Advanced Pancreatic Cancer | Drug: Nab-paclitaxel and S-1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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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).

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients have good compliance, can understand the research process of this study, and sign a written informed consent
- Patients with pathologically confirmed pancreatic adenocarcinoma.
- Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
- Patients with locally advanced pancreatic cancer ( NCCN Version 1,2019 criteria).
- ECOG PS 0-1;
- Tumor size is measurable according to RECIST1.1 criteria
- Expected survival over 3 months;
- Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
- Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
- No contraindications to the use of S-1 and nab-paclitaxel.
Exclusion Criteria:
- ≥ Grade 2 existing peripheral neuropathy;
- Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
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Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
- Not able to take medicine orally.
- Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
- Participation in other clinical trial within 30 days before the first dose of the drug;

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 Cheng | 861069158315 | cnchengyuejuan@yahoo.com |
China, Beijing | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing, China | |
Contact: YueJuan Cheng 861069158315 cnchengyuejuan@yahoo.com |
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT03885219 |
Other Study ID Numbers: |
HS-1751 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | March 10, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |