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

NCT03833466 | Unknown Phase 2

• 1 other identifier: ESCC-MTPneo
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Advanced Esophageal Squamous Cell Carcinoma; Neoadjuvant Therapy; Metformin; Cisplatin; Paclitaxel

Outcome Measures

Primary Outcomes (2)

• Tumor metabolic pathway

  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

  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 Outcomes (1)

• Rate of pathologic complete response（pCR）

  Through study completion, an average of 1 year

Study Arms (1)

metformin and chemotherapy

EXPERIMENTAL

Drug: metformin and chemotherapy

Interventions

metformin and chemotherapy DRUG

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.

metformin and chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking Universtiy Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Metformin; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Therapeutics

Study Officials

• Zhihao Lu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihao Lu, MD

CONTACT

86-10-88196561; 13810549767@126.com

Lin Shen, MD

CONTACT

86-10-88196561; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 7, 2019
• Study Start: February 5, 2019
• Primary Completion: March 20, 2020
• Study Completion: June 20, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)