Advanced Pancreatic CancerPhase 4NCT04217096
Efficacy and Safety of Paclitaxel Liposome and S-1 as First-line Therapy in \ Advanced Pancreatic Cancer Patients
A Phase 4 study testing Paclitaxel liposome and S-1 in people with Advanced Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Paclitaxel liposome and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Mar 2023
- Phase
- Phase 4
- 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
- Age ≥18 years and ≤75 years;
- the patients were confirmed as locally advanced or metastatic pancreatic cancer by histopathology;
- At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- The expected survival after surgery ≥3 months;
- Adequate liver/kidney/bone marrow function： Absolute neutrophil count (ANC) ≥1.5×10^9/L; Hemoglobin (Hgb) ≥9g/dL; Platelets (PLT) ≥100×10^9/L; Total bilirubin (TBIL) ≤1.5×ULN; Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤2.5×institutional upper limit of normal (ULN), or ≤5×ULN(hepatic metastases); Serum creatinine level is normal or creatinine clearance rate≥60 mL/min/1.73 m^2.
- Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 7 days before the start of chemotherapy、during the monthly treatment interval and after the last treatment;
- Signed informed content obtained prior to treatment.
Who cannot join
- Symptomatic ascites;
- The target disease has cerebral metastasis;
- Previously received palliative chemotherapy or other palliative systemic therapy for advanced/metastatic pancreatic cancer;
- Previously received treatments based on paclitaxel liposomes or S-1, except for neoadjuvant therapy or adjuvant therapy (before and after R0/R1 excision), which was based on paclitaxel liposomes or S-1(the time of discontinuation of neoadjuvant/adjuvant chemotherapy before admission ≥6 months);
- Received surgical treatment ≤4 weeks before admission;
- Severe cancer-related cachexia and/or known weight loss >15% occurred within one month before admission;
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- The medical history and complications, which may affect patients' ability to participate in the study and their safety during the study, or interfere with explanation of the study results, for example: uncontrolled hypertension, cardiovascular and cerebrovascular diseases such as cerebrovascular accident (≤6 months from the start of the study), myocardial infarction (≤less than 6 months from the start of the study), unstable angina pectoris, heart failure (≥2 grades) (NYHA functional score), severe arrhythmia requiring medication, metabolic dysfunction, severe renal insufficiency;
- Human immunodeficiency virus (HIV) or Hepatitis B Virus（HBV）、hepatitis C virus (HCV) positive with Liver dysfunction;
- Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of admission, excepted cured carcinoma in situ of cervix、basal cell carcinoma of the skin;
- History of allergy or hypersensitivity to any therapeutic ingredient;
- Patients with known active alcohol or drug abuse or dependence;
- Pregnancy, or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives, or breastfeeding women;
- Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Shanghai, 200032
About this study
Official title: A Single-arm, Prospective Study to Evaluate the Efficacy and Safety of the Combination of Paclitaxel Liposome and S-1 as First-line Therapy in Treating Patients With Advanced Metastatic Pancreatic Cancer
The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.
Read the detailed description
Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Paclitaxel liposome, S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel liposomeDrug
Patients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic
S-1Drug
Patients receive S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel liposome + S-1 | Experimental | paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w） Receives: Drug: Paclitaxel liposome; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
Measured: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
Secondary outcomes (5)
Overall Response Rate
To evaluate the Overall Response Rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
Measured: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
overall survival
To evaluate the overall survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
Measured: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Disease control rate
To evaluate the disease control rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
Measured: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
Quality of life (Qol)
To evaluate the Quality of Life of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
Measured: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Adverse events
To evaluate the adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
Measured: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jan 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xian-Jun Yu, M.D., Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217096
- Sponsor's protocol ID
- CSPAC-21
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Study to Evaluate the Efficacy and Safety of the Combination of Paclitaxel Liposome and S-1 as First-line Therapy in Treating Patients With Advanced Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04217096
- Acronym / sponsor ID
- CSPAC-21
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 3 Jan 2020 (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.
The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.
Detailed description
Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel liposome + S-1 | Experimental | Drug: Paclitaxel liposome, Drug: S-1paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤75 years;
- the patients were confirmed as locally advanced or metastatic pancreatic cancer by histopathology;
- At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- The expected survival after surgery ≥3 months;
Key exclusion criteria (13 listed)
- Symptomatic ascites;
- The target disease has cerebral metastasis;
- Previously received palliative chemotherapy or other palliative systemic therapy for advanced/metastatic pancreatic cancer;
- Previously received treatments based on paclitaxel liposomes or S-1, except for neoadjuvant therapy or adjuvant therapy (before and after R0/R1 excision), which was based on paclitaxel liposomes or S-1(the time of discontinuation of neoadjuvant/adjuvant chemotherapy before admission ≥6 months);
- Received surgical treatment ≤4 weeks before admission;
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 |
|---|---|---|
| Paclitaxel liposomePatients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic | Drug | paclitaxel liposome + S-1 |
| S-1Patients receive S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic. | Drug | paclitaxel liposome + S-1 |
Primary outcome
Progression free survival
Time frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
5 secondary outcomes
Overall Response Rate
Time frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
overall survival
Time frame: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Disease control rate
Time frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
Quality of life (Qol)
Time frame: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Adverse events
Time frame: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Xian-Jun Yu, M.D., Ph.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paclitaxel liposome and S-1 in people with Advanced Pancreatic Cancer, run by Fudan University 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 8 inclusion and 13 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 3 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xian-Jun Yu, M.D., Ph.D. (+86 21 64175590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months). 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 3 Jan 2020.