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

NCT ID: NCT03833466

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2020-06-20

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metformin and chemotherapy

Group Type: EXPERIMENTAL

metformin and chemotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhihao Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking Universtiy Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zhihao Lu, MD

Role: CONTACT

13810549767@126.com

86-10-88196561

Lin Shen, MD

Role: CONTACT

linshenpku@163.com

86-10-88196561

Other Identifiers

ESCC-MTPneo

Identifier Type: -

Identifier Source: org_study_id