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This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel and S-1 | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel and S-1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month progression-free survival (PFS) | The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR). | 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. |
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Inclusion Criteria:
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.
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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TaiPing Zhang | Contact | 13520132976 | Tpingzhang@yahoo.com | |
| YueJuan Cheng | Contact | 861069158315 | cnchengyuejuan@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42324245 | Derived | Cao Z, Qiu J, Luo W, Li J, Chen H, Liu Y, Li S, Li F, Yang Y, Cheng Y, Zhang T, Xue H, Bai C, Zhao Y. Nab-paclitaxel plus S-1 induction chemotherapy for patients with locally advanced pancreatic cancer: a multicenter, open-label phase 2 study. Signal Transduct Target Ther. 2026 Jun 22;11(1):243. doi: 10.1038/s41392-026-02741-1. |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| C079198 | S 1 (combination) |
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