NCT05944809CompletedPhase 2
The Effect of Prophylactic TPO Combined with BMS-IMRT to Esophageal Cancer Patients
A Prospective Phase II Study of Prophylactic TPO Combined with Bone Marrow-sparing Intensity-modulated Radiotherapy to Reduce Platelet Inhibition in Patients with Esophageal Cancer Undergoing Concurrent Chemoradiotherapy
Source: ClinicalTrials.gov · Last updated 24 Jan 2025
Brief summary (registry, in English)
The goal of this interventional study is to explore the protective effect of prophylactic TPO combined with bone marrow sparing (BMS)-IMRT in patients with esophageal cancer undergoing concurrent chemoradiotherapy. The main purpose is to reduce the incidence of all grades of thrombocytopenia from 35% to less than 10% by the intervention of study. Participants will initiate concurrent chemoradiotherapy within 2 weeks after enrollment,and they will receive subcutaneous injection of recombinant human thrombopoietin (rhTPO) 15000U once a week during the radiotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 2 Jun 2023
- Start date
- 20 Jul 2023
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- JIANYANG WANG
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05944809
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 32
- From 20 Jul 2023 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy to the chest;
Other illness
- A history of malignancy at other sites, excluding curable non-melanotic skin cancer and cervical carcinoma in situ;
- Patients with existing or suspected (thoracolumbar and pelvic) bone marrow or bone metastases, or a history of bone trauma in this region within 4 weeks;
- Allergy to Gadolinium-based contrast agent;
- Patients with active infection, or combined with rheumatic immune disease, long-term chronic infection, acute infection, etc., so that the body is in an inflammatory state; Blood system diseases with hematopoietic dysfunction;
Who the study is looking for
- Age greater than 18 years and less than or equal to 75 years
- Histopathologically confirmed esophageal squamous/adenocarcinoma, clinical stage I-IV A (according to the 7th edition of AJCC（American Joint Committee on Cancer） 2010; Concurrent chemoradiotherapy (≥45Gy) was planned (regardless of whether the patient had received induction adjuvant chemotherapy).
- Karnofsky performance status score ≥80 ·;
- Life expectancy \>6 months;
- Meet the following laboratory diagnostic criteria:
- Hemoglobin ≥120g/L, white blood cell ≥4.0×109/L, Neutrophil ≥2.0×109/L, platelet ≥100×109/L;
- Participators had not used granulocyte colony-stimulating factor and thrombopoietin within 3 weeks before enrollment.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.