Borderline Resectable Pancreatic CancerPhase 2NCT03850769
Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer
A Phase 2 study testing nab-paclitaxel and S-1 in people with Borderline Resectable Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Borderline Resectable 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 borderline resectable 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 Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable Pancreatic Cancer
This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.
- Conditions
- Borderline Resectable 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 < 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel and S-1 | Experimental | neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles. Receives: Drug: nab-paclitaxel and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
proportion of patients who achieved R0 resection
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 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.
- Other trials for Borderline Resectable 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
- NCT03850769
- Sponsor's protocol ID
- HS-1752
- 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
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 Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03850769
- Acronym / sponsor ID
- HS-1752
- Conditions
- Borderline Resectable 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
- 22 Feb 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 was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.
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-1neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles. |
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 borderline resectable 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 < 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; | Drug | nab-paclitaxel and S-1 |
Primary outcome
R0 resection rate
Time frame: 3 years
proportion of patients who achieved R0 resection
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.
- 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 Borderline Resectable 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, MD (13520132976, Tpingzhang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.