Locally Advanced Pancreatic CancerPhase 2NCT03885219
Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer
A Phase 2 study testing Nab-paclitaxel and S-1 in people with Locally Advanced Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Nab-paclitaxel and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- ≥ 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
YueJuan Cheng, 861069158315, cnchengyuejuan@yahoo.com
About this study
Official title: Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
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.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Nab-paclitaxel and S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel and S-1Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nab-paclitaxel and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Objective Response Rate (ORR)
Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 May 2019
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885219
- Sponsor's protocol ID
- HS-1751
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42324245
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT03885219
- Acronym / sponsor ID
- HS-1751
- Conditions
- Locally Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel and S-1 | Experimental | Drug: Nab-paclitaxel and S-1chemotherapy 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- ≥ 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxel and S-1Nab-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. | Drug | nab-paclitaxel and S-1 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 42324245Cao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel and S-1 in people with Locally Advanced Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TaiPing Zhang (13520132976, Tpingzhang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.