Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment

• Status: Unknown status
• Trial end date: 2019-06-23
• Target enrollment: 0
• Participant gender: All

Summary

We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.

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

Details

• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University
• Treatments: Apatinib; Fluorouracil

Criteria

Inclusion Criteria:

• 1.Male or female patients, age:≥18 years old.

• 2.Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.

• 3.Patients who undergo local or recurrent metastases after surgery and / or radiotherapy and chemotherapy,at least one measurable lesion(tumor lesions CT scan length ≥ 10 mm,lymph node lesions CT scan short diameter ≥ 15 mm,scan layer thickness is not greater than 6 mm).

• 4.The ECOG physical status score: 0 to 2.

• 5.Expected survival ≥ 3 months.

• 6.Subjects received other treatment damage have been restored, which received nitroso or mitomycin interval ≥ 6 weeks; to accept other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;

• 7.The main organs function properly:

1. blood routine examination standards to be met (14 days without blood transfusion and blood products):

1. HB≥90g/L;

2. ANC≥1.5×109/L;

3. PLT≥80×109/L;

2. biochemical tests to meet the following criteria:

1. TBIL<1.5×ULN;

2. ALT and AST<2.5×ULN, and <5×ULN for patients with liver metastases

3. Serum Cr≤1.5×ULN or endogenous creatinine clearance> 45ml/min (Cockcroft-Gault formula);

• 8.The women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use the appropriate method at 8 weeks after the trial and the last given test contraception.For the man, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given;

• 9.Patients should be voluntary to the trial and provide with signed informed consent

Exclusion Criteria:

• 1.Pregnant or lactating women;

• 2.Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with myocardial infarction or myocardial infarction, arrhythmia and grade II heart Incomplete function;

• 3.Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction;

• 4.Coagulation dysfunction(INR>1.5 or prothrombin time (PT)>ULN + 4 seconds or APTT>1.5×ULN),with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;

• 5.with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding;

• 6.Central nervous system metastasis with symptoms;

• 7.The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study