Clinical trial NCT02945267: Nimotuzumab Plus S1 Versus Placebo Plus S1 as Maintenance Treatment in Patients With Unresectable Pancreatic Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Unresectable Pancreatic Cancer
Keywords: Pancreatic Cancer
Unresectable
Maintenance Treatment
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: TTP
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 3 years
measure: OSR
timeFrame: 1-3 years
measure: Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: First Affiliated Hospital of PLA General Hospital
city: Beijing
country: China
facility: Rocket Army General Hospital, PLA
city: Beijing
country: China
facility: The 306TH Hospital of PLA
city: Beijing
country: China
facility: Air Force General Hospital, PLA
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Yi Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: