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

Esophageal Squamous Cell Carcinoma Clinical Trial

— ECMTPneo  

Official title:

Metformin in Combined With Cisplatin Plus Paclitaxel as Neoadjuvant Therapy With Advanced Esophageal Squamous Cell Carcinoma (ESCC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03833466
• Other study ID #: ESCC-MTPneo
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 5, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: February 2019
• Source: Peking University
• Contact: Zhihao Lu, MD
• Phone: 86-10-88196561
• Email: 13810549767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking Universtiy Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of pathologic complete response(pCR)	Rate of pathologic complete response	Through study completion, an average of 1 year