Clinical trial · Interventional
Metformin in Combined With Cisplatin Plus Paclitaxel With Advanced Esophageal Squamous Cell Carcinoma (ECMTPneo)
Metformin in Combined With Cisplatin Plus Paclitaxel as Neoadjuvant Therapy With Advanced Esophageal Squamous Cell Carcinoma (ESCC)
NCT03833466CI-TRIAL-00037114ECMTPneounknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin and chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- metformin and chemotherapy
- interventionNames
- Drug: metformin and chemotherapy
Primary outcomes (2)
- measure
- Tumor metabolic pathway
- timeFrame
- Through study completion, an average of 1 year
- description
- To compare the changes of tumor metabolic pathway of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
- measure
- Tumor microenvironment
- timeFrame
- Through study completion, an average of 1 year
- description
- To compare the changes of tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.