MedTrace Logo

The Effect of Prophylactic TPO Combined with BMS-IMRT to Esophageal Cancer Patients

NCT05944809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-01-24

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Cancer
  • Intensity-modulated Radiation Therapy
  • Concurrent Chemoradiotherapy
  • Thrombocytopenia

Interventions

DRUG

rhTPO

Standard treatment options: Radiotherapy: 95% planning target volume （planning target volume，PTV） ≥45Gy(without simultaneous boost). Concurrent chemotherapy: Weekly regimen: paclitaxel 50mg/m2 d1, nedaplatin/cisplatin 25 mg/m2d1, a total of 5 cycles. Three weeks regimen: paclitaxel 135-175mg/m2 d1, nedaplatin/cisplatin 80mg/m2, a total of 2 cycles. The active bone marrow was determined by magnetic resonance（magnetic resonance，MR）, and the dose limits are: V5\<95%,V10\<85%,V20\<60%，V30\<40%；95%PTV\>45Gy. rhTPO，15000U ih. qw(during the radiotherapy course)

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • JIANYANG WANG

    lead OTHER

Principal Investigators

  • Jianyang Wang, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944809 on ClinicalTrials.gov