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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
GT101 injection to treat cervical cancer
Gemcitabine injection to treat cervical cancer
Progression Free Survival
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Time frame: 3 years
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.
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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.
Time frame: 3 years
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The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Beijing, Beijing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGChinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGGuangxi Medical University Affiliated Cancer Hospital
Guilin, Guangxi, China
RECRUITINGHarbin Medical University Affiliated Cancer Hospital
Ha’erbin, Heilongjjiang, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGXiangya Second Hospital of Central South University
Changsha, Hunan, China
RECRUITINGSoutheast University Affiliated Zhongda Hospital
Nanjing, Jiangsu, China
RECRUITING...and 14 more locations