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Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo) (ECMTPneo)

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
metformin and chemotherapy
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Advanced Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy, Metformin, Cisplatin, Paclitaxel

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having signed informed consent.
  • Age 18 to 70 years old
  • Histologically confirmed esophageal squamous carcinoma
  • Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed advanced ESCC which need neoadjuvant chemotherapy before surgical resection.
  • Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
  • Life expectancy of ≥3 month
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Body Mass Index (BMI) ≥18.5kg/m2
  • WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.5 times ULN，Serum creatinine <1.5 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃.
  • Good compliance

Exclusion Criteria:

  • Have used metformin or biguanide in the past
  • Contraindications of metformin
  • Unable to take metformin orally because of esophageal stenosis
  • Currently receiving other effective regimens
  • Previous anticipate other clinical trial within 4 weeks before entering this study
  • No measurable lesions, eg. pleural fluid and ascites\
  • Only with other previous malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ
  • Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
  • Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis
  • HIV infection, active hepatitis B or hepatitis C
  • Unstable systemic diseases such as poorly controlled diabetes
  • Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT
  • Known hypersensitivity to study drugs
  • Pregnancy or lactation period

Sites / Locations

  • Peking Universtiy Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metformin and chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Tumor metabolic pathway
To compare the changes of tumor metabolic pathway of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
Tumor microenvironment
To compare the changes of tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples

Secondary Outcome Measures

Rate of pathologic complete response（pCR）
Rate of pathologic complete response

Full Information

First Posted
January 22, 2019
Last Updated
February 13, 2019
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT03833466
Brief Title
Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo)
Acronym
ECMTPneo
Official Title
Metformin in Combined With Cisplatin Plus Paclitaxel as Neoadjuvant Therapy With Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2019 (Anticipated)
Primary Completion Date
March 20, 2020 (Anticipated)
Study Completion Date
June 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label phase II trial investigating the effect of metformin in combined with cisplatin plus paclitaxel as neoadjuvant therapy with advanced esophageal squamous cell carcinoma.
Detailed Description
In this prospective phase II study, eligible patients are received cisplatin plus paclitaxel for 2-4 cycles combined with metformin orally. The investigators aim to compare the tumor metabolic pathway and tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Advanced Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy, Metformin, Cisplatin, Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metformin and chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
metformin and chemotherapy
Intervention Description
Drug: Metformin Metformin is orally administered as 500mg bid for 7 days and escaladed to 500mg tid if adverse events are tolerated. Drug: Cisplatin Cisplatin is given at 75mg/m2 intravenously on day 1 of each 21 day cycle. Drug: Paclitaxel Paclitaxel is given at 175mg/m2 intravenously on day 1 of each 21 day cycle.
Primary Outcome Measure Information:
Title
Tumor metabolic pathway
Description
To compare the changes of tumor metabolic pathway of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
Time Frame
Through study completion, an average of 1 year
Title
Tumor microenvironment
Description
To compare the changes of tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Rate of pathologic complete response（pCR）
Description
Rate of pathologic complete response
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having signed informed consent. Age 18 to 70 years old Histologically confirmed esophageal squamous carcinoma Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed advanced ESCC which need neoadjuvant chemotherapy before surgical resection. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment) Life expectancy of ≥3 month Eastern Cooperative Oncology Group (ECOG) 0-1 Body Mass Index (BMI) ≥18.5kg/m2 WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.5 times ULN，Serum creatinine <1.5 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment) No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃. Good compliance Exclusion Criteria: Have used metformin or biguanide in the past Contraindications of metformin Unable to take metformin orally because of esophageal stenosis Currently receiving other effective regimens Previous anticipate other clinical trial within 4 weeks before entering this study No measurable lesions, eg. pleural fluid and ascites\ Only with other previous malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis HIV infection, active hepatitis B or hepatitis C Unstable systemic diseases such as poorly controlled diabetes Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT Known hypersensitivity to study drugs Pregnancy or lactation period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
13810549767@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, MD
Phone
86-10-88196561
Email
linshenpku@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihao Lu, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Universtiy Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo)

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