Pancreatic CancerPhase 3NCT02395016

A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer

A Phase 3 study testing nimotuzumab and Gemcitabine in people with Pancreatic Cancer, run by Biotech Pharmaceutical Co., Ltd. at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Cancer
What is being tested?: nimotuzumab and Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 25 sitesChina
Study dates: Apr 2015to Nov 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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:18-75 years old
KPS≥60
Histological or cytological diagnosis that are unsuitable for radical radiotherapy or surgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (≥6 months to the last adjuvant chemotherapy)
Has at least one objective measurable lesion can be evaluated according to Response Evaluation Criteria in Solid Tumors1.1(Helical CT examination of the longest diameter of target lesions≥10mm, such as lymph node metastasis only need the shortest path ≥15mm)
Life expectancy ≥12 weeks
K-RAS tumor tissue detected as the wild-type

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Aspartate transaminase（AST）/aminotransferase（ALT）≤2.5×ULN，AST /ALT≤5×ULN（if liver metastases）；Total bilirubin≤2×ULN，Total bilirubin≤3×ULN（if liver metastases）；Absolute neutrophil count≥1.5×109/L；Blood platelet≥100×109/L；Hemoglobin≥90 g/L；Creatinine clearance≥60ml/min
Volunteered to participate this study, written informed consent and has a good compliance
Patients of childbearing age and their spouses are willing to take contraceptive measures

Who cannot join

Before this study had received the following treatments：As a means of anti-tumor palliative chemotherapy and molecular targeted therapy.Target lesion had received radiotherapy without progression.within 4 weeks or be participating in clinical trials of other therapeutic/ interventionist clinical trial.
Undergone major surgery within 4 weeks.
The brain metastasis or leptomeningeal metastasis.
Has a history of malignancy other than the pancreatic cancer (except for the cured cervix in situ or basal cell carcinoma, and a five-year cure other cancers).
The merger has symptoms of ascites and requires clinical treatment. Accompanied by other serious disease, including but not limited:Congestive heart failure which is difficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia, Uncontrolled moderate to severe hypertension(systolic blood pressure（SBP）>160 mm Hg or diastolic blood pressure（DBP）>100 mm Hg).Active infection.Diabetes which is difficult to control.Has mental illness which impacts the informed consent and / or compliance program.HIV infection.There is serious illness that other researchers consider is unsuitable to participate this study.
Known allergy to anti-EGFR antibody formulations.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

China25 sites

Beijing Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021
PLA General Hospital (301 Hospital)
Beijing, Beijing Municipality, 100039
Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
General Hospital of Chengdu Military Region
Chengdu, Sichuan, 610083
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, 350000
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, 350014
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150040
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jiangyin City People's Hospital
Jiangyin, Jiangsu, 214400
Jiangsu Province Tumor Hospital
Nanjing, Jiangsu, 210009
Shanghai Jiaotong University Affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Shanghai Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
First People's Hospital Cancer Center, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200080
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Affiliated Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, 710032

Other trials in China

About this study

Official title: A Prospective, Randomized, Controlled, Double-blind, Multi-center Clinical Study of Nimotuzumab Combinated With Gemcitabine Contrast to Placebo Combinated With Gemcitabine in K-RAS Wild-type,Locally Advanced and Metastatic Pancreatic Cancer

Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival（OS）of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer

Read the detailed description

Conditions: Pancreatic Cancer
Being tested: nimotuzumab, Gemcitabine, Placebo
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nimotuzumabDrug
Also called Taixinsheng
nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.
GemcitabineDrug
Gemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.
PlaceboOther
Placebo，400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Study groups in NCT02395016
Study group	Role	What they receive
Nimotuzumab and Gemcitabine	Experimental	nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. Receives: Drug: nimotuzumab; Drug: Gemcitabine
Placebo and Gemcitabine	Placebo comparator	placebo,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. Receives: Drug: Gemcitabine; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival（OS）
The primary endpoint was overall survival (OS, defined as from randomization to death due to any cause).
We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. The primary end point was evaluated in the full analysis set (FAS; all eligible patients who received at least one dose of nimotuzumab/placebo and had one evaluation of efficacy).
Measured: up to 3 years

Secondary outcomes (6)

Time to Progression（TTP）
TTP, defined as from randomization to the first observation of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: up to 3 years
Progression Free Survival（PFS）
PFS, defined as from randomization to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: up to 3 years
Objective Response Rate（ORR）
Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
Measured: Once every eight weeks，up to 5.4 months
Disease Control Rate（DCR）
Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions).
Measured: Once every eight weeks，up to 5.4 months
Clinical Benefit Response（CBR）
The clinical benefit response(CBR)was evaluated every 8 weeks on the basis of the Burris criteria. CBR included pain (intensity of pain and consumption of analgesics), PS (performance status, evaluated according to KPS) and weight changes. Effective is defined as at least one positive improvement in the CBR index (pain, physical status or weight change) and no negative indicator is found, which can be rated as a clinical benefit case.
Measured: every 8 weeks, up to 5.4 months
Number of Participants With Adverse Events
Adverse Events as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Measured: up to 75.2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Nov 2021

First posted20 Mar 2015 (estimated)
Study startApr 2015
Primary completionNov 2021
Study completionNov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02395016
Sponsor's protocol ID: BPL-Nim-PC-1
Status last verified: Apr 2024
First submitted: 17 Jan 2015
Last updated: 4 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Qin S, Li J, Bai Y, Wang Z, Chen Z, Xu R, Xu J, Zhang H, Chen J, Yuan Y, Liu T, Yang L, Zhong H, Chen D, Shen L, Hao C, Fu D, Cheng Y, Yang J, Wang Q, Qin B, Pan H, Zhang J, Bai X, Zheng Q. Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer. J Clin Oncol. 2023 Nov 20;41(33):5163-5173. doi: 10.1200/JCO.22.02630. Epub 2023 Aug 30.
PubMed 37647576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pancreatic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Double-blind, Multi-center Clinical Study of Nimotuzumab Combinated With Gemcitabine Contrast to Placebo Combinated With Gemcitabine in K-RAS Wild-type,Locally Advanced and Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT02395016
Acronym / sponsor ID: BPL-Nim-PC-1
Conditions: Pancreatic Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Biotech Pharmaceutical Co., Ltd.University, hospital or other
Collaborators: NanJing PLA 81 Hospital, Fudan University
Study start: Apr 2015 (actual)
Primary completion: Nov 2021 (actual)
Study completion: Nov 2021 (actual)
First posted: 20 Mar 2015 (estimated)
Results: Posted 4 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nimotuzumab and Gemcitabine	Experimental	Drug: nimotuzumab, Drug: Gemcitabinenimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.
Placebo and Gemcitabine	Placebo comparator	Drug: Gemcitabine, Other: Placeboplacebo,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age:18-75 years old
KPS≥60
Histological or cytological diagnosis that are unsuitable for radical radiotherapy or surgical treatment of locally advanced or metastatic pancreatic adenocarcinoma (≥6 months to the last adjuvant chemotherapy)
Has at least one objective measurable lesion can be evaluated according to Response Evaluation Criteria in Solid Tumors1.1(Helical CT examination of the longest diameter of target lesions≥10mm, such as lymph node metastasis only need the shortest path ≥15mm)
Life expectancy ≥12 weeks

Key exclusion criteria (6 listed)

Before this study had received the following treatments：As a means of anti-tumor palliative chemotherapy and molecular targeted therapy.Target lesion had received radiotherapy without progression.within 4 weeks or be participating in clinical trials of other therapeutic/ interventionist clinical trial.
Undergone major surgery within 4 weeks.
The brain metastasis or leptomeningeal metastasis.
Has a history of malignancy other than the pancreatic cancer (except for the cured cervix in situ or basal cell carcinoma, and a five-year cure other cancers).
The merger has symptoms of ascites and requires clinical treatment. Accompanied by other serious disease, including but not limited:Congestive heart failure which is difficult to control (NYHA III or IV), Unstable angina, Poorly controlled arrhythmia, Uncontrolled moderate to severe hypertension(systolic blood pressure（SBP）>160 mm Hg or diastolic blood pressure（DBP）>100 mm Hg).Active infection.Diabetes which is difficult to control.Has mental illness which impacts the informed consent and / or compliance program.HIV infection.There is serious illness that other researchers consider is unsuitable to participate this study.

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
nimotuzumabAlso: Taixinshengnimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.	Drug	Nimotuzumab and Gemcitabine
GemcitabineGemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.	Drug	Nimotuzumab and Gemcitabine, Placebo and Gemcitabine
PlaceboPlacebo，400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.	Other	Placebo and Gemcitabine

Primary outcome

Overall Survival（OS）
Time frame: up to 3 years
The primary endpoint was overall survival (OS, defined as from randomization to death due to any cause). We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. The primary end point was evaluated in the full analysis set (FAS; all eligible patients who received at least one dose of nimotuzumab/placebo and had one evaluation of efficacy).

6 secondary outcomes

Time to Progression（TTP）
Time frame: up to 3 years
Progression Free Survival（PFS）
Time frame: up to 3 years
Objective Response Rate（ORR）
Time frame: Once every eight weeks，up to 5.4 months
Disease Control Rate（DCR）
Time frame: Once every eight weeks，up to 5.4 months
Clinical Benefit Response（CBR）
Time frame: every 8 weeks, up to 5.4 months
Number of Participants With Adverse Events
Time frame: up to 75.2 months

Results and safety

Results posted to the registry on 4 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nimotuzumab and Gemcitabine	45	30
Placebo and Gemcitabine	45	33

Primary outcome: Overall Survival（OS）

Time frame: up to 3 years. Median (95% Confidence Interval). Unit: months

Measure	Nimotuzumab- Gemcitabine Group n = 41	Placebo-Gemcitabine Group n = 41
Value	10.9 (5.6 to 16.3)	8.5 (5.7 to 10)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 75.2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimotuzumab- Gemcitabine Group	15 of 45 (33.3%)	44 of 45 (97.8%)	36 of 45
Placebo-Gemcitabine Group	5 of 45 (11.1%)	44 of 45 (97.8%)	40 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37647576Qin S, Li J, Bai Y, Wang Z, Chen Z, Xu R, Xu J, Zhang H, Chen J, Yuan Y, Liu T, Yang L, Zhong H, Chen D, Shen L, Hao C, Fu D, Cheng Y, Yang J, Wang Q, Qin B, Pan H, Zhang J, Bai X, Zheng Q. Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer. J Clin Oncol. 2023 Nov 20;41(33):5163-5173. doi: 10.1200/JCO.22.02630. Epub 2023 Aug 30.

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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.

shukui qin, MD, PHD principal investigator

81th Hospital of PLA

jin li, MD, PHD principal investigator

Fudan University

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nimotuzumab and Gemcitabine in people with Pancreatic Cancer, run by Biotech Pharmaceutical Co., Ltd. at 25 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 6 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival（OS） (time frame: up to 3 years). 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 NCT02395016, which also lists 1 linked publication.

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 4 Apr 2024.