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This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with Head and neck recurrent/metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib group | Experimental | Apatinib Mesylate administered as a daily oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | Apatinib Mesylate will be administered orally at 500 mg once daily for 5 consecutive days, and this was followed by a 2-day rest every week; each cycle consisted of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | To determine 6 month PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | from date of enrollment until date of first death from any cause, assessed up to 2 years | 2 years |
| Response rate | CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Response rate will be evaluated by RECIST criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chenping Zhang, M.D. | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Guopei Zhu, M.D. | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36734294 | Derived | Ye L, Zhang L, Li R, Pan X, Li J, Dou S, Jiang W, Wang C, Chen W, Zhu G. Combined all-trans retinoic acid with low-dose apatinib in treatment of recurrent/metastatic head and neck adenoid cystic carcinoma: A single-center, secondary analysis of a phase II study. Cancer Med. 2023 Apr;12(8):9144-9155. doi: 10.1002/cam4.5653. Epub 2023 Feb 3. | |
| 33995600 |
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| 8 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 | through study completion, an average of 2 years |
| Zhu G, Zhang L, Dou S, Li R, Li J, Ye L, Jiang W, Dong M, Ruan M, Yang W, Zhang C. Apatinib in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck: a single-arm, phase II prospective study. Ther Adv Med Oncol. 2021 May 8;13:17588359211013626. doi: 10.1177/17588359211013626. eCollection 2021. |
| D009369 | Neoplasms |