Refractory or Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Prospective Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | June 2020 |
| Est. primary completion date | October 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - 1. Age:18 to 70 years old (man or female); 2. Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma(pathologically diagnosed with supraclavicular lymph node metastasis and anastomotic recurrence ); 3. The distant metastatic is oligotransfera, with radiotherapy indication; 4. Patients with measurable lesions(measuring=10mm on spiral CT scan, satisfying the criteria in RECIST1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Major organ function has to meet the following certeria: 1. For results of blood routine test (without blood transfusion within 14 days) 1. HB=100g/L; 2. ANC=3.0×109/L; 3. PLT=100×109/L; 2. For results of blood biochemical test: 1. TBIL<1.5×ULN; 2. ALT and AST<2.5×ULN, but< 5×ULN if the transferanse elevation is due to liver metastases; 3. Serum creatinine =1ULN , calculated creatinine clearance>50 ml/min(per the Cockcroft-Gault formula); 7. Life expectancy greater than or equal to 3 months; 8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 9. Coagulation function is normal, without active hemorrhage and thrombosis: 1. INR<1.5×ULN 2. APTT<1.5×ULN 3. PT<1.5ULN 10. Participants were willing to join in this study, and written informed consent; 11. Participants were good adherence, cooperate with the follow-up. Exclusion Criteria: - 1. Allergic to apatinib; 2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with class?and above coronary heart disease and arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and cardiac insufficiency; 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with tendency of gastrointestinal bleeding, including the following; 1. Active ulcerative lesions, and defecate occult blood (+ +); 2. Has melena and hematemesis in three months; 3. For defecate occult blood (+) or(+/-) ,must be received gastroscopy, the physicians consider there are potential bleeding risk with ulcers, hemorrhagic diseases; 5. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 6. Patients with thrombosis or anticoagulant drug therapy; 7. Patients with symptoms of central nervous system metastasis; Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 8. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 9. Less than 4 weeks from the last clinical trial; 10. Have received prior treatment with anti- VEGF/VEGFR; 11. Researchers considered there are serious harm to patient safety or affect the patients who have completed the study; 12. Pregnant or lactating women; 13. The researchers think inappropriate. |
| Country | Name | City | State |
|---|---|---|---|
| China | Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
| Lead Sponsor | Collaborator |
|---|---|
| Hebei Medical University Fourth Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began | |
| Secondary | Overall survival | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to 24 months | |
| Secondary | Disease control rate | Baseline to measured progressive disease | tumor assessment every 6 weeks ,up to 24 month | |
| Secondary | Objective response rate | Baseline to measured stable disease | tumor assessment every 6 weeks,up to 24 months | |
| Secondary | Side effects | throughout study | evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |