Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors.

• 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 disease or recurrent intrathoracic disease which could be encompassed within radiation fields.

• White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /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.

• 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.