Unresectable Pancreatic CancerPhase 4NCT02945267
Nimotuzumab Plus S1 Versus Placebo Plus S1 as Maintenance Treatment in Patients With Unresectable Pancreatic Cancer
A Phase 4 study testing Nimotuzumab plus S1 in people with Unresectable Pancreatic Cancer, run by Chinese PLA General Hospital at 7 sites in China.
Trial summary
Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Pancreatic Cancer
- What is being tested?
- Nimotuzumab plus S1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 7 sitesChina
- Study dates
- Sep 2016to Dec 2019
- 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
- 18-75 years;
- Karnofsky Performance Status≥ 60;
- histologically proven locally advanced or metastatic pancreatic cancer,and unsuitable for radiotherapy or surgery resection;
- benefited from the first line treatment of gemcitabine plus nimotuzumab and S1 (complete response+partial response+stable disease);
- at least 4 weeks from the end of the first-line treatment;
- with at least 1 measurable and evaluable lesion;
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- anticipated over survival≥12 weeks;
- AST/ALT≤2.5 ULN (≤5 ULN for patients with hepatic metastases); total bilirubin≤2 ULN （≤3 ULN for patients with hepatic metastases); neutrophil count≥1.5×109/L; platelet counts≥100×109/L; hemoglobin level≥90 g/L; creatinine clearance rate≥ 60 mL/min
- written informed consent
Who cannot join
- previously received the following treatments: anticancer chemotherapy/molecularly targeted therapy as palliative treatment, or targeted chemotherapy and no progression, another interventional clinical trail within 4 weeks;
- underwent major surgery within 4 weeks;
- with brain or leptomeningeal metastases;
- history of malignancy other than pancreatic cancer;
- presented symptomatic abdominal fluid and needed treatment;
- with other serious diseases such as diabetes,active infection;
- known for allergy to anti epidermal growth factor receptor antibody
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Aiping Zhou, Ph.D, 13691161998
First Affiliated Hospital of PLA General Hospital
Beijing, 100048
Nan Du, Ph.D, 13911599657
Rocket Army General Hospital, PLA
Beijing, 100088
Zhaoxia Li, Ph.D, 18910883463
The 306TH Hospital of PLA
Beijing, 100101
Yunge Gao, Ph.D, 13341050946
Air Force General Hospital, PLA
Beijing, 100142
Zaiwen Fan, Ph.D, 18601949919
Beijing Hospital
Beijing, 100730
Bin Ai, Ph.D, 13811887990
Chinese PLA General Hospital
Beijing, 100853
Yi Hu, PhD, 13911031186, huyi0401@aliyun.com
About this study
Official title: A Randomized, Controlled, Double Blind, Multicenter Study of Nimotuzumab Plus S1 Versus Placebo Plus S1 as Maintenance Treatment in Patients With Advanced or Metastatic Pancreatic Cancer After First-line Treatment
Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and progression free survival (PFS) in patients with unresectable pancreatic cancer. However, it is still unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single S-1. Maintenance treatment, as a new treatment pattern, has also been tried in these patients after first line treatment to improve the OS. Thus, this study is designed to compare nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with locally advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of gemcitabine combined with nimotuzumab and S1 (complete response+partial response+stable disease).
Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2), d1-d14, every three weeks for a cycle. Treatment interventions will be stopped under the conditions of disease progression or intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to disease progression since randomization (TTP), secondary points include OS, 3 years overall survival rate (OSR) and safety.
- Conditions
- Unresectable Pancreatic Cancer
- Being tested
- Nimotuzumab plus S1, Placebo plus S1
- Keywords
- Pancreatic Cancer, Unresectable, Maintenance Treatment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab plus S1Drug
Also called Taixinsheng，Tegafur Gimeracil Oteracil Potassium Capsule
Nimotuzumab Injection: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
Placebo plus S1Drug
Also called Tegafur Gimeracil Oteracil Potassium Capsule
Placebo: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab plus S1 | Experimental | Nimotuzumab Injection:400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks; S1:40 mg (Body surface area<1.5 m2) or 60mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle Receives: Drug: Nimotuzumab plus S1 |
| Placebo plus S1 | Active comparator | Placebo:400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks; S1:40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle Receives: Drug: Placebo plus S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTP
Measured: 3 years
Secondary outcomes (3)
OS
Measured: 3 years
OSR
Measured: 1-3 years
Adverse Events
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 posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yihu, Chinese PLA General Hospital
- Investigators
- Yi Hu, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945267
- Sponsor's protocol ID
- PC20150423
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double Blind, Multicenter Study of Nimotuzumab Plus S1 Versus Placebo Plus S1 as Maintenance Treatment in Patients With Advanced or Metastatic Pancreatic Cancer After First-line Treatment
- ClinicalTrials.gov ID
- NCT02945267
- Acronym / sponsor ID
- PC20150423
- Conditions
- Unresectable Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Unresectable, Maintenance Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Background: Monotherapy with S-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine in overall survival (OS) with good tolerability for advanced pancreatic cancer in Asian patients. It is also shown that nimotuzumab plus gemcitabine could improve OS and progression free survival (PFS) in patients with unresectable pancreatic cancer. However, it is still unknown whether nimotuzumab plus S1 would improve more to OS and PFS than single S-1. Maintenance treatment, as a new treatment pattern, has also been tried in these patients after first line treatment to improve the OS. Thus, this study is designed to compare nimotuzumab plus S1 to placebo plus S1 as maintenance treatment in patients with locally advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of gemcitabine combined with nimotuzumab and S1 (complete response+partial response+stable disease).
Patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group nimotuzumab plus S1 and group placebo plus S1. nimotuzumab/placebo: 400 mg/w, intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks. S1: oral, 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2), d1-d14, every three weeks for a cycle. Treatment interventions will be stopped under the conditions of disease progression or intolerable toxic reaction or participants ask to quit. The primary endpoint is the time to disease progression since randomization (TTP), secondary points include OS, 3 years overall survival rate (OSR) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab plus S1 | Experimental | Drug: Nimotuzumab plus S1Nimotuzumab Injection:400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks; S1:40 mg (Body surface area<1.5 m2) or 60mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle |
| Placebo plus S1 | Active comparator | Drug: Placebo plus S1Placebo:400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks; S1:40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-75 years;
- Karnofsky Performance Status≥ 60;
- histologically proven locally advanced or metastatic pancreatic cancer,and unsuitable for radiotherapy or surgery resection;
- benefited from the first line treatment of gemcitabine plus nimotuzumab and S1 (complete response+partial response+stable disease);
- at least 4 weeks from the end of the first-line treatment;
Key exclusion criteria (7 listed)
- previously received the following treatments: anticancer chemotherapy/molecularly targeted therapy as palliative treatment, or targeted chemotherapy and no progression, another interventional clinical trail within 4 weeks;
- underwent major surgery within 4 weeks;
- with brain or leptomeningeal metastases;
- history of malignancy other than pancreatic cancer;
- presented symptomatic abdominal fluid and needed 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 |
|---|---|---|
| Nimotuzumab plus S1Also: Taixinsheng，Tegafur Gimeracil Oteracil Potassium CapsuleNimotuzumab Injection: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle | Drug | Nimotuzumab plus S1 |
| Placebo plus S1Also: Tegafur Gimeracil Oteracil Potassium CapsulePlacebo: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle | Drug | Placebo plus S1 |
Primary outcome
TTP
Time frame: 3 years
3 secondary outcomes
OS
Time frame: 3 years
OSR
Time frame: 1-3 years
Adverse Events
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 26 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Yi Hu, PhD principal investigator
Chinese PLA General Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nimotuzumab plus S1 in people with Unresectable Pancreatic Cancer, run by Chinese PLA General Hospital at 7 sites 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 9 inclusion and 7 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Yi Hu, PhD (13911031186, huyi0401@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTP (time frame: 3 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 26 Oct 2016.