CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 57 target
Drug / intervention
Thymosin a1 +2 moredrug
Likely dose
Thymosin a1 1.6mgfrom 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/NCT03663764
NCT03663764Phase 2Unknown

Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study

Sun Yat-sen University·interventional·Posted Sep 10, 2018·Updated Dec 10, 2021

In Brief

A Phase 2 clinical trial evaluating Thymosin a1, hypofractionated radiotherapy, and 1 other intervention for Thymoma and Thymic Carcinoma. Targeting 57 participants across 1 site.

Detailed Summary

This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
20192020202120222023202420252026
First PostedSep 10, 2018
Enrollment StartAug 13, 2018
Primary CompletionAug 1, 2023
TodayJul 1, 2026
Enrollment to primary: 5.0 yearsPosted 7.8 years ago

Interventions

Thymosin a1drug

All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

hypofractionated radiotherapyradiation

HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.

concurrent chemoradiotherapydrug

All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .