Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, Apatinib, Irinotecan Read More

Inclusion Criteria:

• Patients must have histologically confirmed esophageal squamous cell carcinoma with relapse disease and the primary tumor have been surgically removed.

  • With measurable or evaluable disease defined by RECIST 1.1 criteria by multi-slice spiral CT or MRI scan.
  • - Failed in or disease progressed after fist-line chemotherapy (If failed in perioperative chemotherapy or disease progressed in 24 weeks after perioperative chemotherapy, the perioperative chemotherapy is regard as first-line chemotherapy )
  • - Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • - Without serious system dysfunction and could tolerate chemotherapy.
  • - With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a neutrophil count of ≥2.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
  • - Life expectancy ≥3 months
  • - With normal electrocardiogram results and no history of congestive heart failure.
  • - Without bleeding and thrombosis disease
  • - With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN
  • - Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
  • - With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • - With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

• Patients who have received irinotecan or apatinib in previous treatment.
• Primary tumor is not resected.
• Uncontrolled hypertension (after treatment with antihypertensive drugs cannot reduced to the normal range: systolic pressure <140 mmHg and diastolic pressure <90 mmHg)
• With ≥ grade 2 coronary heart disease, arrhythmia (including corrected QT interval prolongation male >450 ms, women >470 ms)
• Cannot take oral tables including uncontrolled vomiting, chronic diarrhea and intestinal obstruction.
• With potential bleeding risk including (1) peptic ulcer and fecal occult blood (++); (2) melena or hematemesis history in last 3 months; (3) fecal occult blood (+) or (+/-) and endoscopy showed ulcer or other diseases with bleeding risk.
• With abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN),
• With thrombosis or receiving anticoagulant treatment.
• With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
• With brain metastasis of tumor
• Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment).