CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
rhTPOdrug
Likely dose
rhTPO 50mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05944809
NCT05944809Phase 2Completed
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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

JIANYANG WANG·interventional·Posted Jul 13, 2023·Updated Jan 24, 2025

In Brief

A Phase 2 clinical trial evaluating rhTPO for Esophageal Cancer and 3 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer, Intensity-modulated Radiation Therapy, Concurrent Chemoradiotherapy, Thrombocytopenia
CountriesChina
CollaboratorsCancer Institute and Hospital, Chinese Academy of Medical Sciences

Timeline

Phase 2CompletedFinished
202420252026
First PostedJul 13, 2023
Enrollment StartJul 20, 2023
Primary CompletionJun 30, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.0 years ago

Interventions

rhTPOdrug

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)