Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.
Interventions
COMBINATION_PRODUCTApatinib,Paclitaxel,Cisplatin,RT
Apatinib Mesylate Tablets 250mg qd p.o. d1-35; Paclitaxel：50mg/m2 iv d1，8，15，22，29; Cisplatin: 30mg/m2 iv d1，8，15，22，29; RT：41.4Gy/23f , 1.8Gy/f，5 f/w
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age:18 to 70 years old (man or female); 2. Pathologically diagnosed with esophageal squamous cell carcinoma; 3. Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography; 4. Patients with measurable lesions(According to the criteria in RECIST1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Life expectancy greater than or equal to 3 months; 7. Major organ function has to meet the following certeria: (1) For results of blood routine test 1. HB≥80g/L; 2. ANC≥1.5×109/L; 3. PLT≥90×109/L; (2) For results of blood biochemical test a) ALT and AST≤2.5×ULN; b) TBIL\<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
1. Have received prior treatment with chemotherapy or radiotherapy； 2. Have high blood pressure and antihypertensive drug treatment can not control; 3. Patients with severe cardiovascular disease ; 4. Accompanied by esophageal perforation and esophagotracheal fistula; 5. Patients with active bleeding or bleeding tendency; 6. Pregnant or lactating women; 7. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pathological complete response rate(pCR) | within 3 weeks after surgery | The lesion disappeared completely by pathology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0-resection rate | within 3 weeks after surgery | There was no residual by the microscope |
| Disease-free survival(DFS) | 3 years | Baseline to measured date of recurrence or death from any cause |
| Overall survival (OS) | 1year | Baseline to measured date of death from any cause |
| Adverse events Toxicity | 3 years | Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit. |
Outcome results
None listed