Pancreatic CancerNCT03443921
Divestment for Artery-involved Pancreatic Cancer
A study testing Artery Divestment Technique and Nab-paclitaxel in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Locally Advanced Pancreatic Cancer, Neoadjuvant Therapy
- What is being tested?
- Artery Divestment Technique and Nab-paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Mar 2018to Mar 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT\&MRI scan and tumor markers;
- Age > 18 year and <80 year;
- Agree to participate in the study with signed informed consent.
Who cannot join
- Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
- Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
- Focal vessel narrowing or contour irregularity revealed by radiology examinations;
- Economic situations cannot afford designed treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yi Miao, MD, PhD, +86-25-68136508, miaoyi@njmu.edu.cn
About this study
Official title: Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial
Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.
Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.
- Conditions
- Pancreatic Cancer, Locally Advanced Pancreatic Cancer, Neoadjuvant Therapy, Borderline Resectable Pancreatic Cancer
- Being tested
- Artery Divestment Technique, Nab-paclitaxel
- Keywords
- Artery Divestment Technique, Locally Advanced Pancreatic Cancer, Neoadjuvant Therapy, Borderline Resectable Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artery Divestment TechniqueProcedure or surgery
Also called Sub-adventitial Resection
Tunica adventitia was pick up by forceps and opened by electrocoagulation at 1 cm distal from tumor-artery contact. Space between tunica adventitia and external elastic lamina (EEL) were blunt lifting tumor-invaded adventitia by angled clamp. Adventitia was then sectioned to show EEL. Loose dissect space could be achieve along long the plane between EEL and adventitia as long as tumor invasion outside EEL. Tumor and invaded adventitia were further cut open by electrocoagulation proximally. Circumferentially, separation could be done by blunt dissection around EEL. Nourishing blood vessels of the artery would be secured by electrocoagulation or ultrasonic scalpel while major branch would be ligated or transfixed.
Nab-paclitaxelDrug
After eligibility testing as blood tests, contrast-enhanced CT and MRI scan, 3 cycles were administered (1,000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 every 28 days).Patients will be reevaluated and curative operation would be attempted if without disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Experimental | In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. Receives: Procedure: Artery Divestment Technique |
| NeoChemo Group | Active comparator | In NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression. Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality at one year after randomization;
Measured: 1 year
Secondary outcomes (22)
Overall survival rate after 2 years from randomization;
Measured: 2 years
Overall survival rate after 3 years from randomization;
Measured: 3 years
Median survival
Measured: 3 years
Disease-free survival
Measured: 3 years
Margin status of subjects receiving curative surgery
The margin status will be reported as R0, R1 and R2 according to AJCC Cancer Staging Manual 8th ed.
Measured: 1 years
Intra-operative blood transfusion
For both Surgery Group and participants who received operations in NeoChemo Group, category and volume of intra-operative blood transfusion will be reported.
Measured: 1 years
Intra-operative blood loss
For both Surgery Group and participants who received operations in NeoChemo Group, intra-operative blood loss will be measured and reported by milliliter.
Measured: 1 years
Overall surgical complication rate
Overall surgical complication rate for both Surgery Group and participants who received operations in NeoChemo Group will be reported. Post-operative pancreatic fistula, delayed gastric emptying, post-operative hemorrhage, Surgical site infection and other surgical complications will be recorded. Percentage that candidates suffered from surgical complications of surgical cases for both group will be reported.
Measured: 1 years
Incidence of post-operative pancreatic fistula
Post-operative pancreatic fistula (POPF) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of post-operative pancreatic fistula of surgical cases in both group will be reported.
Measured: 1 years
Incidence of delayed gastric emptying
Delayed gastric emptying (DGE) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of DGE of surgical cases in both group will be reported.
Measured: 1 years
Incidence of post-operative hemorrhage
Post-operative hemorrhage (POH) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of POH of surgical cases in both group will be reported.
Measured: 1 years
Incidence of surgical site infection
Surgical site infection was assessed as US CDC guidelines.Incidence of surgical site infection of surgical cases in both group will be reported.
Measured: 1 years
Incidence of other surgical complications
Any other undesirable situations that considered complicated with surgery will be recorded. Incidence of other surgical complications of surgical cases in both group will be reported.
Measured: 1 years
Severe adverse events rate
Feasibility of chemotherapy will be evaluated according to Common Terminology Criteria for Adverse Events, US NCI. Participants receiving neo-adjuvant, adjuvant or palliative chemotherapy will be accessed. Grade 3-5 adverse events, dose reduction or dose delay will be reported.
Measured: 3 years
Quality of life at 0.5 year after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Measured: 0.5 year
Quality of life at 1 year after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Measured: 1 year
Quality of life at 2 years after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Measured: 2 years
Quality of life at 3 years after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Measured: 3 years
Performance status at 0.5 year after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Measured: 0.5 year
Performance status at 1 year after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Measured: 1 year
Performance status at 2 years after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Measured: 2 years
Performance status at 3 years after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
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 posted23 Feb 2018
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 The First Affiliated Hospital with Nanjing Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Miao, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443921
- Sponsor's protocol ID
- NMU-JSPH-PC-DIV
- Status last verified
- Feb 2018
- First submitted
- 17 Dec 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Nov 27;371(22):2140-1. doi: 10.1056/NEJMc1412266. No abstract available.
PubMed 25427123Zhang H, Wroblewski K, Jiang Y, Penney BC, Appelbaum D, Simon CA, Salgia R, Pu Y. A new PET/CT volumetric prognostic index for non-small cell lung cancer. Lung Cancer. 2015 Jul;89(1):43-9. doi: 10.1016/j.lungcan.2015.03.023. Epub 2015 Apr 9.
PubMed 25936471Tang K, Lu W, Qin W, Wu Y. Neoadjuvant therapy for patients with borderline resectable pancreatic cancer: A systematic review and meta-analysis of response and resection percentages. Pancreatology. 2016 Jan-Feb;16(1):28-37. doi: 10.1016/j.pan.2015.11.007. Epub 2015 Dec 2.
PubMed 26687001Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
PubMed 28055103Seufferlein T, Bachet JB, Van Cutsem E, Rougier P; ESMO Guidelines Working Group. Pancreatic adenocarcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii33-40. doi: 10.1093/annonc/mds224. No abstract available.
PubMed 22997452Fortner JG, Kim DK, Cubilla A, Turnbull A, Pahnke LD, Shils ME. Regional pancreatectomy: en bloc pancreatic, portal vein and lymph node resection. Ann Surg. 1977 Jul;186(1):42-50. doi: 10.1097/00000658-197707000-00007.
PubMed 195543Chua TC, Saxena A. Extended pancreaticoduodenectomy with vascular resection for pancreatic cancer: a systematic review. J Gastrointest Surg. 2010 Sep;14(9):1442-52. doi: 10.1007/s11605-009-1129-7. Epub 2010 Apr 9.
PubMed 20379794
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03443921
- Acronym / sponsor ID
- NMU-JSPH-PC-DIV
- Conditions
- Pancreatic Cancer, Locally Advanced Pancreatic Cancer, Neoadjuvant Therapy, Borderline Resectable Pancreatic Cancer
- Keywords
- Artery Divestment Technique, Locally Advanced Pancreatic Cancer, Neoadjuvant Therapy, Borderline Resectable Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 23 Feb 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 the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.
Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | Experimental | Procedure: Artery Divestment TechniqueIn Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. |
| NeoChemo Group | Active comparator | Drug: Nab-paclitaxelIn NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT\&MRI scan and tumor markers;
- Age > 18 year and <80 year;
- Agree to participate in the study with signed informed consent.
Key exclusion criteria (4 listed)
- Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
- Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
- Focal vessel narrowing or contour irregularity revealed by radiology examinations;
- Economic situations cannot afford designed treatment.
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 |
|---|---|---|
| Artery Divestment TechniqueAlso: Sub-adventitial ResectionTunica adventitia was pick up by forceps and opened by electrocoagulation at 1 cm distal from tumor-artery contact. Space between tunica adventitia and external elastic lamina (EEL) were blunt lifting tumor-invaded adventitia by angled clamp. Adventitia was then sectioned to show EEL. Loose dissect space could be achieve along long the plane between EEL and adventitia as long as tumor invasion outside EEL. Tumor and invaded adventitia were further cut open by electrocoagulation proximally. Circumferentially, separation could be done by blunt dissection around EEL. Nourishing blood vessels of the artery would be secured by electrocoagulation or ultrasonic scalpel while major branch would be ligated or transfixed. | Procedure or surgery | Surgery Group |
| Nab-paclitaxelAfter eligibility testing as blood tests, contrast-enhanced CT and MRI scan, 3 cycles were administered (1,000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 every 28 days).Patients will be reevaluated and curative operation would be attempted if without disease progression. | Drug | NeoChemo Group |
Primary outcome
Overall mortality at one year after randomization;
Time frame: 1 year
22 secondary outcomes
Overall survival rate after 2 years from randomization;
Time frame: 2 years
Overall survival rate after 3 years from randomization;
Time frame: 3 years
Median survival
Time frame: 3 years
Disease-free survival
Time frame: 3 years
Margin status of subjects receiving curative surgery
Time frame: 1 years
Intra-operative blood transfusion
Time frame: 1 years
Intra-operative blood loss
Time frame: 1 years
Overall surgical complication rate
Time frame: 1 years
Incidence of post-operative pancreatic fistula
Time frame: 1 years
Incidence of delayed gastric emptying
Time frame: 1 years
Incidence of post-operative hemorrhage
Time frame: 1 years
Incidence of surgical site infection
Time frame: 1 years
Incidence of other surgical complications
Time frame: 1 years
Severe adverse events rate
Time frame: 3 years
Quality of life at 0.5 year after randomization
Time frame: 0.5 year
Quality of life at 1 year after randomization
Time frame: 1 year
Quality of life at 2 years after randomization
Time frame: 2 years
Quality of life at 3 years after randomization
Time frame: 3 years
Performance status at 0.5 year after randomization
Time frame: 0.5 year
Performance status at 1 year after randomization
Time frame: 1 year
Performance status at 2 years after randomization
Time frame: 2 years
Performance status at 3 years after randomization
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 25427123Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Nov 27;371(22):2140-1. doi: 10.1056/NEJMc1412266. No abstract available.
- Background: PubMed 25936471Zhang H, Wroblewski K, Jiang Y, Penney BC, Appelbaum D, Simon CA, Salgia R, Pu Y. A new PET/CT volumetric prognostic index for non-small cell lung cancer. Lung Cancer. 2015 Jul;89(1):43-9. doi: 10.1016/j.lungcan.2015.03.023. Epub 2015 Apr 9.
- Background: PubMed 26687001Tang K, Lu W, Qin W, Wu Y. Neoadjuvant therapy for patients with borderline resectable pancreatic cancer: A systematic review and meta-analysis of response and resection percentages. Pancreatology. 2016 Jan-Feb;16(1):28-37. doi: 10.1016/j.pan.2015.11.007. Epub 2015 Dec 2.
- Background: PubMed 28055103Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
- Background: PubMed 22997452Seufferlein T, Bachet JB, Van Cutsem E, Rougier P; ESMO Guidelines Working Group. Pancreatic adenocarcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii33-40. doi: 10.1093/annonc/mds224. No abstract available.
- Background: PubMed 195543Fortner JG, Kim DK, Cubilla A, Turnbull A, Pahnke LD, Shils ME. Regional pancreatectomy: en bloc pancreatic, portal vein and lymph node resection. Ann Surg. 1977 Jul;186(1):42-50. doi: 10.1097/00000658-197707000-00007.
- Background: PubMed 20379794Chua TC, Saxena A. Extended pancreaticoduodenectomy with vascular resection for pancreatic cancer: a systematic review. J Gastrointest Surg. 2010 Sep;14(9):1442-52. doi: 10.1007/s11605-009-1129-7. Epub 2010 Apr 9.
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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 study testing Artery Divestment Technique and Nab-paclitaxel in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 3 inclusion and 4 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 23 Feb 2018. 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.
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 Yi Miao, MD, PhD (+86-25-68136508, miaoyi@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality at one year after randomization; (time frame: 1 year). 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 NCT03443921, which also lists 7 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 23 Feb 2018.