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

NCT02945267 | Unknown Phase 4 DMC

• 1 other identifier: PC20150423
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

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.

Conditions

Unresectable Pancreatic Cancer

Keywords

Pancreatic Cancer; Unresectable; Maintenance Treatment

Outcome Measures

Primary Outcomes (1)

• TTP

  3 years

Secondary Outcomes (3)

• OS

  3 years

• OSR

  1-3 years

• Adverse Events

  3 years

Study Arms (2)

Nimotuzumab plus S1

EXPERIMENTAL

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

Placebo plus S1

ACTIVE COMPARATOR

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

Interventions

Nimotuzumab plus S1 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

Also known as: Taixinsheng，Tegafur Gimeracil Oteracil Potassium Capsule

Nimotuzumab plus S1

Placebo plus S1 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

Also known as: Tegafur Gimeracil Oteracil Potassium Capsule

Placebo plus S1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (7)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

First Affiliated Hospital of PLA General Hospital

Beijing, 100048, China

Location

Rocket Army General Hospital, PLA

Beijing, 100088, China

Location

The 306TH Hospital of PLA

Beijing, 100101, China

Location

Air Force General Hospital, PLA

Beijing, 100142, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

nimotuzumab; S 1 (combination)

Condition Hierarchy (Ancestors)

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

Study Officials

• Yi Hu, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Hu, PhD

CONTACT

13911031186; huyi0401@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)