esophageal cancer
Conditions
Interventions
Research Group:Prophylactic Use of Recombinant Human Platelet Growth Factor During Radical Radiotherapy
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. =18 years, any gender; 2. Histologically confirmed esophageal squamous cell carcinoma; 3. Suitable for radical radiotherapy; 4. Patients with a risk score of =99.4 according to our research team's predictive model for platelet reduction during radiation therapy (corresponding to a 42% risk). 5. No significant abnormalities in laboratory tests, including complete blood count, liver and kidney function; serum urea nitrogen, creatinine, transaminase and bilirubin <1.5 times the upper limit of normal; normal prothrombin time. 6. No severe cardiovascular or pulmonary diseases; 7. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Active infection currently exists. The following conditions occurred within 6 months before randomization: myocardial infarction, cerebrovascular accident, or received gastrointestinal, neurological, cardiopulmonary surgery; 2. High risk of embolism such as those with atrial fibrillation or deep vein thrombosis. 3. Combine with spontaneous bleeding. 4. Participate in other clinical trials at present or within 4 weeks before enrollment; 5. High risk of perforation that radiotherapy cannot be safely carried out as assessed by radiation oncologists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Icidence of thrombocytopenia during radiotherapy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall incidence of thrombocytopenia during radiotherapy;Incidence of Grade 3 or higher thrombocytopenia;Overall Survival;Progression-Free Survival;Incidence of Acute Toxicity;Incidence of Late Toxicity (defined as occurring three months after the end of treatment);Platelet Molecular Markers in Predicting Efficacy of Radiotherapy and Immunotherapy;Correlation between Platelet-Related Molecular Markers and Incidence of Toxicity; | — |
Countries
China
Contacts
Public ContactWen-Yang Liu
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed