Brief Summary: In this study, effects of γδ T cells on Advanced hepatocyte carcinoma The goal of this clinical trial is to learn about effects of allogeneic γδ T therapy in advanced hepatocyte carcinoma patients. The main question it aims to answer is:Will advanced hepatocyte carcinoma patients be benefit from allogeneic γδ T therapy? Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
Zhuhai People'S Hospital
Zhuhai, Guangdong, China
The change of performance status score
In medicine(oncology and Other fields), performance status is an attempt to Quantify cancer patients' general well-being and activities of daily life.This measure is used to determine whether they can receive chemotherapy, whether dose adjustment is necessary,and as a measure for the required intensity of palliative care. It is also used in oncological randomized controlled trials as a measure of quality of life. PS scores range from 1 to 5,with Higher PS score indicating worse prognosis.
Time frame: up to approximately 16months
The Child-Pugh score
The Child-Pugh score is a system for assessing the prognosis-including the required strength of treatment and necessity of liver transplant-of chronic liver disease. It provides a forecast of the increasing severity of liver disease and expected survival rate.Child-Pugh scores range from 5 to 15, with higher scores indicating worse prognosis.Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15;)
Time frame: up to approximately 16months
Overall Survival
From the date of entry into the clinical study until death from any cause
Time frame: Up to 16months
ORR(objective remission rate )
ORR is defined as the percentage of participants in the analysis population who have a Complete Responseor a Partial Response . CR: Disappearance of all target lesions PR: at least 30% decrease in the sum of diameters of target lesions
Time frame: up to approximately 16months
TTP(time to disease progression )
Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression .Patients that die of causes unrelated to the study drug without evidence of progression will be censored. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.
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Time frame: up to approximately 16months
DoR(duration of remission )
The duration of response (DoR) is measured from the time the criteria are met for CR or PR (whichever is first recorded) until the date that recurrent or progressive disease is documented. CR: Disappearance of all target lesions PR: at least 30% decrease in the sum of diameters of target lesions
Time frame: up to approximately 16months
DCR (disease control rate)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD. CR(complete response):Disappearance of all target lesions PR( partial response):at least 30% decrease in the sum of diameters of target lesions SD(stable disease):any cases that do not qualify for either partial response or progressive disease.
Time frame: up to approximately 16months
PFS(Progression-Free Survival )
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of objective disease progression or death from any cause without evidence of disease progression, whichever comes first.
Time frame: up to approximately 16months