Locally Advanced Pancreatic CancerPhase 2NCT03815461
Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
A Phase 2 study testing Nab-paclitaxel and S-1 in people with Locally Advanced Pancreatic Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Nab-paclitaxel and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 2 Oct 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient compliance is good, the research process of this study can be understood, and written informed consent is signed;
- Age ≥ 18 years old, ≤ 75 years old;
- Histologically or cytologically confirmed pancreatic adenocarcinoma；
- no prior treatment;
- Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines);
- ECOG<2;
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- Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L;
- Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin < 1.5 × ULN;
- Renal function: serum creatinine is within normal range;
- Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment;
- Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment;
- No contraindication to the use of S-1and albumin-bound paclitaxel.
Who cannot join
- Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer);
- Interstitial pneumonia or pulmonary fibrosis;
- Severe pleural effusion or ascites;
- Watery diarrhea;
- There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder;
- Current or previous patients with grade II peripheral neuropathy;
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- Abnormal digestive tract or metabolic function, which may affect the s-1 absorber;
- Participated in other clinical researchers within 4 weeks prior to enrollment;
- Patients who have undergone organ transplantation;
- Patients considered by the investigator to be unfit for this trial.
Trial locations and contacts
1 site in 1 country.
Zhou Aiping contact
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Zhou Aiping, +86 13691161998, zhouap1825@126.com
About this study
Official title: Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .
Read the detailed description
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.
During the study, if the subject's weight change was ≤10% from baseline, the dose was calculated based on the measured value at baseline. If the change was >10%, the body surface area of the subject should be recalculated and the dose administered should be adjusted. .
Study treatment period Borderline resectable: According to the results of imaging examination, MDT discussed to determine the surgical resectability and timing of surgery. The chemotherapy time was 4-6 cycles.
Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging examination, MDT determined the resectability of the operation. It was decided by the investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or radiotherapy.
- 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 was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | Nab-paclitaxel+S-1 Receives: Drug: Nab-paclitaxel and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: up to 2.5 years
Secondary outcomes (4)
R0 resection rate
Measured: 6 months
Overall survival rate
Measured: 2 years
Overall survival
Measured: up to 2.5 years
Adverse reaction rate
Measured: up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion2 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Zhou Aiping, Principal investigator, National Cancer Center/Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815461
- Sponsor's protocol ID
- CSPC-KAL-PC-05
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03815461
- Acronym / sponsor ID
- CSPC-KAL-PC-05
- Conditions
- Locally Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 2 Oct 2023 (estimated)
- First posted
- 24 Jan 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 single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .
Detailed description
This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.
During the study, if the subject's weight change was ≤10% from baseline, the dose was calculated based on the measured value at baseline. If the change was >10%, the body surface area of the subject should be recalculated and the dose administered should be adjusted. .
Study treatment period Borderline resectable: According to the results of imaging examination, MDT discussed to determine the surgical resectability and timing of surgery. The chemotherapy time was 4-6 cycles.
Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging examination, MDT determined the resectability of the operation. It was decided by the investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Drug: Nab-paclitaxel and S-1Nab-paclitaxel+S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- patient compliance is good, the research process of this study can be understood, and written informed consent is signed;
- Age ≥ 18 years old, ≤ 75 years old;
- Histologically or cytologically confirmed pancreatic adenocarcinoma；
- no prior treatment;
- Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines);
Key exclusion criteria (10 listed)
- Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer);
- Interstitial pneumonia or pulmonary fibrosis;
- Severe pleural effusion or ascites;
- Watery diarrhea;
- There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder;
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 was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles. | Drug | experiment group |
Primary outcome
PFS
Time frame: up to 2.5 years
4 secondary outcomes
R0 resection rate
Time frame: 6 months
Overall survival rate
Time frame: 2 years
Overall survival
Time frame: up to 2.5 years
Adverse reaction rate
Time frame: up to 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
Zhou Aiping contact
Zhou Aiping principal investigator
National Cancer Center/Cancer Hospital, China
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 Chinese Academy of Medical Sciences 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 12 inclusion and 10 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 25 Jan 2019. 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 Zhou Aiping (+86 13691161998, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 2.5 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 25 Jan 2019.