Pancreatic CancerPhase 2NCT03779464
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
A Phase 2 study testing S1 or Gemcitabine in people with Pancreatic Cancer and Nab-paclitaxel, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer, Nab-paclitaxel, Gemcitabine
- What is being tested?
- S1 or Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Sep 2021
- 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
- Histological or cytological confirmation of pancreatic adenocarcinoma
- Distant metastatic or unresctable locally advanced diseases
- CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
- At least one lesion measurable by RECIST v1.1 criteria
- Life expectancy> 3 months
- No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
Show all 15Show fewer
- No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
- Pain must be monitored before inclusion
- 18 years < age < 70
- Performance status: 0-1
- ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
- ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
- Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
- creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
- Patient information and signature of 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, 1 recruiting
- Recruiting
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yu Hu, MD, 027-85726114, 284409937@qq.com
About this study
Official title: Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
Read the detailed description
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.
- Conditions
- Pancreatic Cancer, Nab-paclitaxel, Gemcitabine, S1
- Being tested
- S1 or Gemcitabine
- Keywords
- pancreatic cancer, nab-paclitaxel, gemcitabine, S1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1 or GemcitabineDrug
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
| Study group | Role | What they receive |
|---|---|---|
| S/nab | Experimental | Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w) Receives: Drug: S1 or Gemcitabine |
| Gem/nab | Active comparator | Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w) Receives: Drug: S1 or Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 6 month
Secondary outcomes (4)
OS
overall survival
Measured: 1 year
ORR
objective response rate
Measured: 6 month
DCR
CR+PR+SD was defined as disease control rate (DCR)
Measured: 6 month
Safety profile :Adverse events of nab-Paclitaxel plus S-1
Adverse events of nab-Paclitaxel plus S-1
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 posted19 Dec 2018
- Study start1 Aug 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779464
- Sponsor's protocol ID
- XHZL-001
- Status last verified
- Jul 2019
- First submitted
- 17 Dec 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PubMed 24131140Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
PubMed 23547081Xu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1;48(6):535-541. doi: 10.1093/jjco/hyy063.
PubMed 29718363
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT03779464
- Acronym / sponsor ID
- XHZL-001
- Conditions
- Pancreatic Cancer, Nab-paclitaxel, Gemcitabine, S1
- Keywords
- pancreatic cancer, nab-paclitaxel, gemcitabine, S1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 19 Dec 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.
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
Detailed description
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S/nab | Experimental | Drug: S1 or GemcitabineNab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w) |
| Gem/nab | Active comparator | Drug: S1 or GemcitabineNab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological or cytological confirmation of pancreatic adenocarcinoma
- Distant metastatic or unresctable locally advanced diseases
- CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
- At least one lesion measurable by RECIST v1.1 criteria
- Life expectancy> 3 months
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 |
|---|---|---|
| S1 or GemcitabineGemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w) | Drug | Gem/nab, S/nab |
Primary outcome
PFS
Time frame: 6 month
progression-free survival
4 secondary outcomes
OS
Time frame: 1 year
ORR
Time frame: 6 month
DCR
Time frame: 6 month
Safety profile :Adverse events of nab-Paclitaxel plus S-1
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Results publication: PubMed 24131140Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
- Results publication: PubMed 23547081Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
- Results publication: PubMed 29718363Xu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1;48(6):535-541. doi: 10.1093/jjco/hyy063.
- 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 S1 or Gemcitabine in people with Pancreatic Cancer and Nab-paclitaxel, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 15 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 8 Jul 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 Zhenyu lin, MD (86-27-85871982, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 month). 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 NCT03779464, which also lists 3 linked publications.
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 8 Jul 2019.