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

NCT02395016 | Completed Phase 3 Results

• 1 other identifier: BPL-Nim-PC-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 25

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 3 years

Secondary Outcomes (6)

• Time to Progression（TTP）

  up to 3 years

• Progression Free Survival（PFS）

  up to 3 years

• Objective Response Rate（ORR）

  Once every eight weeks，up to 5.4 months

• Disease Control Rate（DCR）

  Once every eight weeks，up to 5.4 months

• Clinical Benefit Response（CBR）

  every 8 weeks, up to 5.4 months

Study Arms (2)

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.

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.

Drug: Gemcitabine; Other: Placebo

Interventions

nimotuzumab DRUG

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

Also known as: Taixinsheng

Nimotuzumab and Gemcitabine

Gemcitabine 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.

Nimotuzumab and Gemcitabine; Placebo and Gemcitabine

Placebo OTHER

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

Placebo and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead
• NanJing PLA 81 Hospital: collaborator
• Fudan University: collaborator

Study Sites (25)

First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Location

PLA General Hospital (301 Hospital)

Beijing, Beijing Municipality, 100039, China

Location

Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fuzhou General Hospital of Nanjing Military Region

Fuzhou, Fujian, 350000, China

Location

Fujian Provincial Tumor Hospital

Fuzhou, Fujian, 350014, China

Location

Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150040, China

Location

Jiangyin City People's Hospital

Jiangyin, Jiangsu, 214400, China

Location

Jiangsu Province Tumor Hospital

Nanjing, Jiangsu, 210009, China

Location

Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

Location

Shanghai Jiaotong University Affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

First People's Hospital Cancer Center, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200080, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Affiliated Xijing Hospital, Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

General Hospital of Chengdu Military Region

Chengdu, Sichuan, 610083, China

Location

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 37647576 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

nimotuzumab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Biotech Pharmaceutical Co., Ltd.

lucy_he@biotechplc.com

010-51571020

Study Officials

• shukui qin, MD, PHD

  81th Hospital of PLA

  PRINCIPAL INVESTIGATOR

• jin li, MD, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2015
• First Posted: March 20, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Locations

CN (25)