esophagus cancer
Conditions
Interventions
Experimental group:Apatinib combined with Tegafur Gimeracil Oteracil Potassium Capsule
Sponsors
Shanxi Provincial Tumour Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years- 75 years,male or female; 2. Advanced squamous cell carcinoma of the esophagus diagnosed by histopathology and / or cytology,with measurable focus(Spiral CT scan=10mm,satisfied RECIST 1.1 standard); 3. Locally advanced or Inability topical treatment of recurrence or rejection of topical treatment , more than patients with advanced squamous cell carcinoma of the esophagus who failed first-line chemotherapy; (1) Definition of treatment failure:disease progression during treatment ,or metastasis occurs after treatment,or toxicity that can not be tolerated; (2) The disease progresses every first-line treatment including medication time more than one or more chemotherapy for 1 cycles or longer; early stage adjuvant / neoadjuvant therapy is permitted, if the auxiliary / neoadjuvant therapy during or after less than 24 weeks in the tumor recurrence and metastasis, it is considered that neoadjuvant / neoadjuvant therapy is a first-line systemic chemotherapy for progressive diseases; 4. ECOG PS:0-2 component; 5. The main organs are functioning normally and meet the following requirements: ABlood routine examination, need to meet (no blood transfusion within 14 days) HB=90g/L; ANC=1.5×10^9/L; PLT=70×10^9/L; BBiochemical tests should meet the following criteria: BIL <1.5ULN; ALT and AST<2.5×ULN; serum Cr=1×ULN, CrCl=50ml/min (Cockcroft-Gault formula). 6. The expected survival time more than 3 months; 7. The patient volunteered to join the study and signed informed consent(ICF).
Exclusion criteria
Exclusion criteria: 1. Suffering from hypertension and failing to be reduced to normal range by antihypertensive medication(systolic pressure>140 mmHg/diastolic pressure>90 mmHg),with more than grade II coronary heart diseasearrhythmia (including prolongation of QTc interval, male > 450 ms, female > 470 MS) and cardiac insufficiency; 2. There are many factors that influence the absorption of oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 3. Special note: patients with gastrointestinal bleeding risk are not eligible for inclusion, including the following: aWith active peptic ulcer lesions, and fecal occult blood (+ + + +); b1 months have melena, hematemesis history; cFor fecal occult blood (+ +) and primary esophageal tumor lesions without surgical, gastroscopy must be performed, if it is an ulcer type of esophageal cancer, and the doctor thinks it may cause the bleeding of the lesion; 4. Abnormal coagulation function(PT-S>16 secondsINR>1.5×ULNAPTT>1.5×ULN),bleeding prone; 5. Symptomatic metastasis of the central nervous system; 6. Pregnant or lactating women; 7. Other physicians considered unfit for inclusion; 8. Patients who were not actively associated with follow-up; 9. The first-line treatment used in patients with Tegafur Gimeracil Oteracil Potassium Capsule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate ; | — |
Countries
China
Contacts
Public ContactYusheng Wang
Shanxi Provincial Tumour Hospital
Outcome results
None listed