Study of Thymosin a1 During Chemoradiotherapy For Unresectable Thymoma and Thymic Carcinoma
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ClinicalTrials.gov Identifier: NCT03663764 |
Recruitment Status :
Recruiting
First Posted : September 10, 2018
Last Update Posted : September 11, 2018
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Condition or disease | Intervention/treatment | Phase |
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Thymoma and Thymic Carcinoma | Drug: Thymosin a1 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 57 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Phase Ⅱ Study of Thymosin a1 During Chemoradiotherapy For Unresectable Thymoma and Thymic Carcinoma |
Actual Study Start Date : | August 13, 2018 |
Estimated Primary Completion Date : | August 2023 |
Estimated Study Completion Date : | August 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Expeiment
Patients in experimental group 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.
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Drug: Thymosin a1
All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy. |
- Progression-Free Survival [ Time Frame: 3 years ]
- Time to a 10 point (10%) deterioration in Quality of Life score [ Time Frame: 3 years ]EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire
- Overall Survival [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ≥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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663764
Contact: Bo Qiu, Attending | +86-020-87343031 | qiubo@sysucc.org.cn | |
Contact: Hui Liu, Professor | +86-020-87343031 | liuhui@sysucc.org.cn |
China, Guangdong | |
Sun yat-sen University Cancer Center | Recruiting |
Guangzhou, Guangdong, China, 510000 | |
Contact: Bo Qiu, Attending +86-020-87343031 qiubo@sysucc.org.cn | |
Contact: Hui Liu, Professor |
Principal Investigator: | Hui Liu, Professor | Sun Yat-sen University |
Responsible Party: | Hui Liu, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT03663764 |
Other Study ID Numbers: |
GASTO-1042 |
First Posted: | September 10, 2018 Key Record Dates |
Last Update Posted: | September 11, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Unresectable Thymoma and Thymic Carcinoma Chemoradiotherapy Thymosin a1 |
Carcinoma Thymoma Thymus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Complex and Mixed Thoracic Neoplasms Neoplasms by Site Lymphatic Diseases |