- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833466
Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo) (ECMTPneo)
February 13, 2019 updated by: Shen Lin, Peking University
Metformin in Combined With Cisplatin Plus Paclitaxel as Neoadjuvant Therapy With Advanced Esophageal Squamous Cell Carcinoma (ESCC)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Shen, MD
- Phone Number: 86-10-88196561
- Email: linshenpku@163.com
Study Contact Backup
- Name: Zhihao Lu, MD
- Phone Number: 86-10-88196561
- Email: 13810549767@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Peking Universtiy Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: metformin and chemotherapy
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor metabolic pathway
Time Frame: Through study completion, an average of 1 year
|
To compare the changes of tumor metabolic pathway of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
|
Through study completion, an average of 1 year
|
Tumor microenvironment
Time Frame: Through study completion, an average of 1 year
|
To compare the changes of tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of pathologic complete response(pCR)
Time Frame: Through study completion, an average of 1 year
|
Rate of pathologic complete response
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhihao Lu, MD, Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 5, 2019
Primary Completion (Anticipated)
March 20, 2020
Study Completion (Anticipated)
June 20, 2020
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (Actual)
February 7, 2019
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 13, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Metformin
Other Study ID Numbers
- ESCC-MTPneo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Squamous Cell Carcinoma
-
Cancer Institute and Hospital, Chinese Academy...Akeso Pharmaceuticals, Inc.Not yet recruitingMetastatic Esophageal Squamous Cell Carcinoma | Unresectable Esophageal Squamous Cell Carcinoma | Locally Advanced Esophageal Squamous Cell Carcinoma
-
National Cancer Institute (NCI)TerminatedEsophageal Cancer | Esophageal Neoplasms | Esophageal Adenocarcinoma | Squamous Cell Carcinoma | Esophageal Squamous Cell CancerUnited States
-
Peking UniversityUnknownAdvanced Esophageal Squamous CarcinomaChina
-
Fujian Medical University Union HospitalNot yet recruitingEsophageal Squamous Cell Carcinoma Thoracic Stage II | Esophageal Squamous Cell Carcinoma Thoracic Stage III | Esophageal Squamous Cell Carcinoma Thoracic Stage IVChina
-
The First Affiliated Hospital of Henan University...Luoyang Central Hospital; Nanyang Central Hospital; Sanmenxia Central Hospital; Military 150 Hospital and other collaboratorsActive, not recruitingStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
Jiangsu Cancer Institute & HospitalRecruitingLocally Advanced Esophageal CarcinomaChina
-
Shanghai Zhongshan HospitalZhejiang Cancer Hospital; Sun Yat-sen University; Cancer Institute and Hospital... and other collaboratorsRecruitingEsophageal Squamous Cell Carcinoma Stage II | Esophageal Squamous Cell Carcinoma Stage IIIChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell Carcinoma | Stage I Esophageal Adenocarcinoma | Stage II Esophageal Adenocarcinoma | Stage III Esophageal Adenocarcinoma | Stage I Esophageal Squamous Cell CarcinomaChina
Clinical Trials on metformin and chemotherapy
-
Hager salah el dinCompletedMetastatic Breast CancerEgypt
-
Beni-Suef UniversityCompleted
-
University of ChicagoSuspendedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Brenner Tumor | Malignant Ascites | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer and other conditionsUnited States
-
Peking Union Medical College HospitalNot yet recruitingCervical Cancer | Hypoxia | Radiotherapy | Metformin | PET/CT
-
Sun Yat-sen UniversityUnknown
-
International Atomic Energy AgencyCompletedNon Small Cell Lung CancerChile, China, Croatia, Egypt, India, Malaysia, Malta, Morocco, Pakistan, Panama, Peru, South Africa, Tunisia
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Anji PharmaSuspendedDiabetes Mellitus, Type 2Spain, United States, Canada, Hungary, Brazil, Czechia, Poland, Bulgaria
-
University Health Network, TorontoBristol-Myers SquibbRecruiting
-
Ping LiangNot yet recruitingChemotherapy | Liver Metastases | Colorectal Carcinoma