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

NCT ID: NCT02945267

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unresectable Pancreatic Cancer

Keywords

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Pancreatic Cancer Unresectable Maintenance Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Nimotuzumab plus S1

Intervention Type DRUG

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 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

Group Type ACTIVE_COMPARATOR

Placebo plus S1

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Taixinsheng，Tegafur Gimeracil Oteracil Potassium Capsule Tegafur Gimeracil Oteracil Potassium Capsule

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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yihu

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

First Affiliated Hospital of PLA General Hospital

Beijing, , China

Site Status

Rocket Army General Hospital, PLA

Beijing, , China

Site Status

The 306TH Hospital of PLA

Beijing, , China

Site Status

Air Force General Hospital, PLA

Beijing, , China

Site Status

Beijing Hospital

Beijing, , China

Site Status

Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yi Hu, PhD

Role: CONTACT

Phone: 13911031186

Email: [email protected]

Facility Contacts

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Aiping Zhou, Ph.D

Role: primary

Nan Du, Ph.D

Role: primary

Zhaoxia Li, Ph.D

Role: primary

Yunge Gao, Ph.D

Role: primary

Zaiwen Fan, Ph.D

Role: primary

Bin Ai, Ph.D

Role: primary

Yi Hu, PhD

Role: primary

Other Identifiers

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PC20150423

Identifier Type: -

Identifier Source: org_study_id