esophageal cancer
Conditions
Interventions
Experience group:Docetaxel 75mg/m2, first day, 21 days a week Anlotinib 12 mg/tablet, one tablet at a time, once a day, before meals (take at the same time every day as possible). Continuous oral adm
Sponsors
Nanyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-75 years male and female; 2) Pathologically confirmed esophageal squamous cell carcinoma; 3) Advanced patients with advanced esophageal squamous cell carcinoma who failed to receive first-line radiotherapy and chemotherapy; 4) According to RECIST 1.1 standard, patients have at least one measurable target lesion (CT scan length of tumor lesion (> 10 mm); 5) The estimated survival time is more than 3 months; 6) ECOG PS score: 0-2; 7) without molecular targeted drug therapy; 8) With well main organs function, the relevant pre-randomized examination indicators meet the following requirements: (1) blood routine examination: Hemoglobin (>90 g/L); The number of neutrophils more than 1.5 x 10^9/L; Platelet count > 100 *10^9/L; Leukocyte count > 3.5 x 10^9/L; (2) biochemical examination: Total bilirubin 50 ml/min;(Cockcroft-Gault formula); 9) Pregnancy test (serum or urine) results must be negative within 7 days before admission, and appropriate contraceptive methods should be used voluntarily during observation and within 8 weeks after the last administration of Anlotinib tablets; 10) The patients voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Participated in clinical studies of other drugs within four weeks before screening; 2) Those who had previously received Apatinib or other inhibitors of VEGFR, such as bevacizumab, sorafenib and sunitinib; 3) There are many factors affecting oral medicines (such as inability to swallow, chronic diarrhea and intestinal obstruction); 4) Symptomatic brain metastasis and cancerous meningitis (patients with brain metastasis who had completed treatment 21 days before admission and whose symptoms were stable could be admitted to the group, but no symptoms of cerebral hemorrhage were confirmed by craniocerebral MRI, CT or venography evaluation); (5) Patients with hypertension who could not be reduced to normal range by antihypertensive drugs (systolic pressure > 140 mmHg/diastolic pressure > 90 mmHg), coronary heart disease (> grade II), arrhythmia (including prolonged QTc interval in males > 450 ms, females > 470 ms) and cardiac insufficiency; 6) Urinary routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification (>1.0 g); 7) Patients with other malignant tumors within 5 years; Allergies to docetaxel, anlotinib and/or their adjuvants have been confirmed; 8) those who have a history of psychotropic drug abuse and can not be withdrawn or have mental disorders; 9) Having bleeding tendency or receiving thrombolytic or anticoagulant therapy; 10) Abnormal coagulation function (INR > 1.5 *ULN, APTT > 1.5 *ULN), with bleeding tendency; 11) Those with a clear tendency of gastrointestinal bleeding, including those with locally active ulcer lesions, and fecal occult blood (++) could not be included in the group; those with a history of melena and hematemesis within 2 months; 12) Pregnant or lactating women; 13) Researchers believe that patients are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Disease control rate;Overall Survival;Quality of life;Side effects; | — |
Countries
China
Contacts
Public ContactWan Li Xin
Nanyang Central Hospital
Outcome results
None listed