FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 23, 2022
  • participants needed
    35
  • sponsor
    Yuhong Li
Updated on 23 January 2021

Summary

This phase study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.

Description

Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.

Details
Condition Advanced Esophageal Carcinoma
Treatment FOLFIRI
Clinical Study IdentifierNCT02023593
SponsorYuhong Li
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients have provided a signed Informed Consent Form
Karnofsky score 70
Age: 18-75 years old
Histologically confirmed diagnosis of advanced esophageal carcinoma
Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy
Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
Life expectancy 3 months
Patient has adequate bone marrow and organ function
Absolute Neutrophil Count (ANC) 1.5 x 109/L
Platelets 75 x 109/L
Hemoglobin 9.0 g/dL
Patient has adequate liver function
AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
Serum bilirubin 2 x ULN
Creatinine 1.5 times ULN
Good compliance

Exclusion Criteria

Pregnant or lactating women
Brain metastasis or only with bone metastasis
Patients with severe infection or active peptic ulcer which need treatment
Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases
Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ
Psychiatric illness that would prevent the patient from giving informed consent
Patient is concurrently using other approved or investigational antineoplastic agent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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