Advanced Pancreatic CancerPhase 2NCT03415802
Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer
A Phase 2 study testing Nab-paclitaxel and S-1 in people with Advanced Pancreatic Cancer, run by Aiping Zhou at 1 site in China.
Trial summary
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. 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?
- Nab-paclitaxel and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2015to 11 Jul 2019
- 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
- Age, years: 18-75
- Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
- Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
- Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
- Both male and female subjects of potential fertility have to agree effective birth control during the entire study
- Informed consent
Who cannot join
- Concurrent other effective treatment (including radiotherapy)
- Resectable patients
- Allergy history to other drugs in the same class patients with pregnancy or lactation
- Known severe internal medical diseases
- Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
- Immunocompromised patients, such as HIV positive
- Uncontrollable mental illness
- Other conditions the researchers considered ineligible for the study
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official title: Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.
Read the detailed description
Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer.
Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan.
We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Nab-paclitaxel and S-1
- Keywords
- Nab-Paclitaxel, S-1, Advanced Pancreatic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel and S-1Drug
Also called Abraxane,Tegafur, Gimeracil and Oteracil Porassium
Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel Plus S-1 | Experimental | Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w) Receives: Drug: Nab-paclitaxel and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
CR+PR was defined as objective response rate (ORR)
Measured: 6 month
Secondary outcomes (4)
DCR
CR+PR+SD was defined as disease control rate (DCR)
Measured: 6 month
PFS
From date of randomization until date of first documented PD, date of death
Measured: 6 month
OS
From date of randomization until date of death
Measured: 1 year
Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer
Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start11 May 2015
- Primary completion11 Jul 2017
- Study completion11 Jul 2019
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.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiping Zhou
- Responsible party
- Sponsor-investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Aiping Zhou, Doctor, Principal investigator, National Cancer Center/Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415802
- Sponsor's protocol ID
- CH-GI-062
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2018
- Last updated
- 1 Feb 2021
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT03415802
- Acronym / sponsor ID
- CH-GI-062
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- Nab-Paclitaxel, S-1, Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aiping Zhou
- Study start
- 11 May 2015 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 30 Jan 2018 (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.
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.
Detailed description
Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer.
Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan.
We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen.
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 Plus S-1 | Experimental | Drug: Nab-paclitaxel and S-1Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; 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 (6 listed)
- Age, years: 18-75
- Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
- Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
- Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
- Both male and female subjects of potential fertility have to agree effective birth control during the entire study
Key exclusion criteria (8 listed)
- Concurrent other effective treatment (including radiotherapy)
- Resectable patients
- Allergy history to other drugs in the same class patients with pregnancy or lactation
- Known severe internal medical diseases
- Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
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-1Also: Abraxane,Tegafur, Gimeracil and Oteracil PorassiumNab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w) | Drug | Nab-paclitaxel Plus S-1 |
Primary outcome
Objective response rate（ORR）
Time frame: 6 month
CR+PR was defined as objective response rate (ORR)
4 secondary outcomes
DCR
Time frame: 6 month
PFS
Time frame: 6 month
OS
Time frame: 1 year
Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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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.
Aiping Zhou, Doctor 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 Advanced Pancreatic Cancer, run by Aiping Zhou 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 6 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: finished, as of the sponsor's last update on 1 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: 6 month). 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 1 Feb 2021.