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

NCT ID: NCT02395016

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2021-11-30

Brief Summary

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

Detailed Description

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.Secondary objectives include time to progression（TTP）,progression-free survival（PFS）,Objective Response Rate（ORR）,Disease Control Rate（DCR）,Clinical Benefit Response（CBR）and safety.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nimotuzumab and Gemcitabine

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.

Group Type: EXPERIMENTAL

nimotuzumab

Intervention Type: DRUG

nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Gemcitabine

Intervention Type: DRUG

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,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.

Group Type: PLACEBO_COMPARATOR

Gemcitabine

Intervention Type: DRUG

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

Intervention Type: OTHER

Placebo，400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Interventions

nimotuzumab

nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Intervention Type: DRUG

Gemcitabine

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.

Intervention Type: DRUG

Placebo

Placebo，400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.

Intervention Type: OTHER

Other Intervention Names

Taixinsheng

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NanJing PLA 81 Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

shukui qin, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

81th Hospital of PLA

jin li, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, China

PLA General Hospital (301 Hospital)

Beijing, Beijing Municipality, China

Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fuzhou General Hospital of Nanjing Military Region

Fuzhou, Fujian, China

Fujian Provincial Tumor Hospital

Fuzhou, Fujian, China

Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Jiangyin City People's Hospital

Jiangyin, Jiangsu, China

Jiangsu Province Tumor Hospital

Nanjing, Jiangsu, China

Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Shanghai Jiaotong University Affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanghai Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

First People's Hospital Cancer Center, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Affiliated Xijing Hospital, Fourth Military Medical University

Xi’an, Shanxi, China

General Hospital of Chengdu Military Region

Chengdu, Sichuan, China

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37647576 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BPL-Nim-PC-1

Identifier Type: -

Identifier Source: org_study_id