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This is an investigational, single arm study.
Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use chemotherapy combined with pembrolizumab to treat thymoma or Thymic carcinoma.
Subjects will be evaluated for eligibility during a 28-day screening period. Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Up to 40 participants will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy+Pembrolizumab | Experimental | Chemotherapy combined with pembrolizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy+Pembrolizumab. | Drug | Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). After 4 cycles treatment, complete response subjects continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, some of partial disease and stable disease subjects can receive surgical treatment. And then continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, other partial disease and stable disease subjects cannot be removed by surgery will continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab for 4 cycles and then pembrolizumab or Normal Saline up to disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate. | Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). | After 4 cycles (each cycle is 21 days) treatment up to 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival. | Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). | After 4 cycles (each cycle is 21 days) treatment up to 4 years. |
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Inclusion Criteria:
Have a histologically or cytologically confirmed diagnosis of unresectable thymoma or thymic carcinoma.
Have measurable disease based on RECIST 1.1.
Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymoma or thymic carcinoma.
Patients who could provision of archival to evaluate the PD-L1 expression status.
Be ≥ 18 years of age on day of signing informed consent.
Life expectancy > 3 months.
Have a performance status (PS) of 0 or 1 on the ECOG PS.
Demonstrate adequate organ function as defined below all screening labs should be performed.
Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongan Zhou | Contact | 86-13700287519 | Zhou.yongan@163.com | |
| Xunliang Yin | Contact | 86-13389283977 |
| Name | Affiliation | Role |
|---|---|---|
| Yongan Zhou | Tang-Du Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | China |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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|
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |