Chimeric Antigen Receptor T Cells (CART) Therapy in GUYC2C postive Digestive system tumors, include colorectal cancer, gastric cancer, liver cancer, pancreatic cancer, adenocarcinoma of esophagus, cancer of the esophagogastric junction. Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.
The primary objective of phase 1 is to evaluate the safety of CART regimens. The primary objective of phase 2 is to evaluate the efficacy of CART, as measured by objective response rate in subjects with colorectal cancer. Secondary objectives will include assessing the safety and tolerability of CART and additional efficacy endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients with advanced malignant gastrointestinal tumors were injected with CART cells
Anhui provincial cancer hospital
Hefei, Anhui, China
Number of participants with CAR-T treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 24 months ]
The investigator is responsible for ensuring that all adverse events observed by the investigator or reported by the subject during the 3-month period from enrollment (i.e. initiation of leukocyte separation) to 3 months after targeted car-t infusion are monitored and reported. After three months, researchers will be required to monitor and report targeted adverse events, including neurological, blood, infection, autoimmune diseases, and secondary malignant tumors, for 24 months or until disease progression, whichever occurs first.
Time frame: 24 months
The event of cytokine release syndrome was reported using the grading scale in the protocol.
We will summarize the classification of cytokine release syndrome (CRS) according to the severity and system organ classification.
Time frame: 24 months
Efficacy will be assessed according to RECIST1.1 or EORTC or PERCIST criteria
Remission will be evaluated by the central investigator at the time indicated in the evaluation plan. The disease was evaluated according to the response evaluation criteria in solid tumors RECIST version 1.1 or EORTC or percist. Flow cytometry, molecular or cytogenetic studies used in the trial will be used to assist, but will not be used alone to determine remission.
Time frame: 24 months
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