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This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT101 injection treatment group | Experimental |
| |
| Gemcitabine injection treatment group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT101 injection | Biological | GT101 injection to treat cervical cancer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first. | 3 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XiaoHua Wu, PHD | Contact | 021-64175590 | wu.xh@fudan.edu.cn | |
| Jing Wang, PHD | Contact | wangjing0081@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of the General Hospital of the People's Liberation Army of China | Recruiting | Beijing | Beijing Municipality | 222002 | China |
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| Gemcitabine injection |
| Drug |
Gemcitabine injection to treat cervical cancer |
|
Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0. |
| 3 years |
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
|
| Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518172 | China |
|
| Guangxi Medical University Affiliated Cancer Hospital | Recruiting | Guilin | Guangxi | 530021 | China |
|
| Harbin Medical University Affiliated Cancer Hospital | Recruiting | Ha’erbin | Heilongjjiang | 150081 | China |
|
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 450052 | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
|
| Xiangya Second Hospital of Central South University | Recruiting | Changsha | Hunan | 410012 | China |
|
| Southeast University Affiliated Zhongda Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| Jiangxi Maternal and Child Health Hospital | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| Affiliated Zhongshan Hospital Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
|
| Dalian Medical University First Affiliated Hospital | Recruiting | Dalian | Liaoning | 116001 | China |
|
| Shandong First Medical University Affiliated Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
|
| Jining First People's Hospital | Recruiting | Jining | Shandong | 272002 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Fudan University Affiliated Obstetrics and Gynecology Hospital | Recruiting | Shanghai | Shanghai Municipality | 214432 | China |
|
| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030013 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| Sichuan University West China Second Hospital | Recruiting | Chengdu | Sichuan | 610044 | China |
|
| Yibin Second People's Hospital | Recruiting | Yibin | Sichuan | 644002 | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300181 | China |
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| Yun Cancer Hospital | Recruiting | Kunming | Yunnan | 650118 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| ID | Term |
|---|---|
| C038643 | dimethyl-2-(tetrahydro-2-furanyl)ethylsulfonium |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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