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Nimotuzumab Plus S1 Versus Placebo Plus S1 as Maintenance Treatment in Patients With Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02945267
Recruitment Status : Not yet recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
yihu, Chinese PLA General Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Unresectable Pancreatic Cancer Drug: Nimotuzumab plus S1 Drug: Placebo plus S1 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nimotuzumab plus S1
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
Drug: Nimotuzumab plus S1
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
Other Name: Taixinsheng,Tegafur Gimeracil Oteracil Potassium Capsule

Active Comparator: Placebo plus S1
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
Drug: Placebo plus S1
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
Other Name: Tegafur Gimeracil Oteracil Potassium Capsule




Primary Outcome Measures :
  1. TTP [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. OS [ Time Frame: 3 years ]
  2. OSR [ Time Frame: 1-3 years ]
  3. Adverse Events [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945267


Contacts
Contact: Yi Hu, PhD 13911031186 huyi0401@aliyun.com

Locations
China
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, China, 100021
Contact: Aiping Zhou, Ph.D    13691161998      
First Affiliated Hospital of PLA General Hospital Not yet recruiting
Beijing, China, 100048
Contact: Nan Du, Ph.D    13911599657      
Rocket Army General Hospital, PLA Not yet recruiting
Beijing, China, 100088
Contact: Zhaoxia Li, Ph.D    18910883463      
The 306TH Hospital of PLA Not yet recruiting
Beijing, China, 100101
Contact: Yunge Gao, Ph.D    13341050946      
Air Force General Hospital, PLA Not yet recruiting
Beijing, China, 100142
Contact: Zaiwen Fan, Ph.D    18601949919      
Beijing Hospital Not yet recruiting
Beijing, China, 100730
Contact: Bin Ai, Ph.D    13811887990      
Chinese PLA General Hospital Not yet recruiting
Beijing, China, 100853
Contact: Yi Hu, PhD    13911031186    huyi0401@aliyun.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Yi Hu, PhD Chinese PLA General Hospital

Responsible Party: yihu, , Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02945267     History of Changes
Other Study ID Numbers: PC20150423
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by yihu, Chinese PLA General Hospital:
Pancreatic Cancer
Unresectable
Maintenance Treatment

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents