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COVID1-19 pandemic
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| Name | Class |
|---|---|
| Jinan University Guangzhou | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDKM-100 injection | Experimental | In this trial, the patients will receive multiple high-activity γδ T cell immunotherapies.The trial is divided into two parts: Part 1 is a multiple-dose escalation trial consisting of 3 dose groups (2×10^8 cells/person, 5×10^8 cells/person, 10×10^8 cells/person at 1-3 infusion, 4-6 infusion and 7-9 infusion), with 9 patients planned to be enrolled. Part 2 is a single dose trial in which doctor and the PI evaluates whether to give the rest patients to receive the 10×10^8 cells/person infusions based on available safety data. The check indexes are CT scan，intestinal flora detection and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDKM-100 injection | Biological | Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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;) | up to approximately 16months |
| Overall Survival | From the date of entry into the clinical study until death from any cause | Up to 16months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to approximately 16months |
| TTP（time to disease progression ) |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Zhi nan Yin, PhD.MD. | Jinan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhuhai People'S Hospital | Zhuhai | Guangdong | 519050 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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. |
| 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 | 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. | 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. | up to approximately 16months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |