A Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma

Hebei Medical University

Status and phase: Terminated; Phase 2

Conditions: Refractory or Metastatic Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: apatinib S-1 radiotherapy; Combination Product: S-1 radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03320629

HRA-E01

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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:

  2. 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;

  3. 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:
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     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 classⅡand 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;

  2. Active ulcerative lesions, and defecate occult blood (+ +);

  3. Has melena and hematemesis in three months;

  4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

apatinib and S-1 radiotherapy

Experimental group

Description:

apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Combination Product: apatinib S-1 radiotherapy

S-1 radiotherapy

Active Comparator group

Description:

S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Combination Product: S-1 radiotherapy