Clinical trial · Interventional
FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma
Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma
NCT02023593CI-TRIAL-00063984completedPhase 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 phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal 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 |
|---|---|---|---|
| Advanced Esophageal Carcinoma | Esophageal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI
- description
- Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
- interventionNames
- Drug: FOLFIRI
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- Up to 24 weeks
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- From the date of first drug administration until the date of death, assessed up to 60months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.