Study of Thymosin a1 During Chemoradiotherapy For Unresectable Thymoma and Thymic Carcinoma

  • STATUS
    Recruiting
  • End date
    Aug 22, 2023
  • participants needed
    57
  • sponsor
    Sun Yat-sen University
Updated on 22 January 2021
carcinoma
chemotherapy regimen
solid tumors
biotherapy
thymic carcinoma
thymic neoplasm

Summary

This Phase II study is to determine the efficacy of thymosin a1 during chemoradiotherapy for unresectable thymoma and thymic carcinoma

Description

This Phase II study is to determine the efficacy of thymosin a1 during chemoradiotherapy for unresectable thymoma and thymic carcinoma.

All patients received four cycles of weekly docetaxel(25mg/) and nedaplatin(25mg/), each of 1 day's duration, combined with thoracic radiotherapy of 66 Gy/22 fractions. Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Details
Condition Thymoma, Thymomas, thymic carcinoma
Treatment Thymosin a1
Clinical Study IdentifierNCT03663764
SponsorSun Yat-sen University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologic confirmation of thymoma or thymic carcinoma
Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Unresectable, refusing surgery or after R2 surgery
Previously treated with chemotherapy or treatment-naive
No previous chest radiotherapy, immunotherapy or biotherapy
White blood cell count 4109 /L, neutrophile granulocyte count1.5109 /L, platelet count100109 /L, hemoglobin 100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN
FEV1 >0.8 L
CB6 within normal limits
Patients and their family signed the informed consents

Exclusion Criteria

Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation
Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia)
Malignant pleural effusion or pericardial effusion
Weight loss >10% within the past 3 months
Recruited in other clinical trials within 30 days
Drug addiction, long-term alcohol abuse and AIDS patients
Uncontrollable epileptic attack or psychotic patients without self-control ability
Severe allergy or idiosyncrasy
Not suitable for this study judged by researchers
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