FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li
• Treatments: Fluorouracil; Irinotecan; Leucovorin

Criteria

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