CART Therapy in Digestive System Tumors
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|ClinicalTrials.gov Identifier: NCT04780529|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Digestive Organs||Biological: gucy2c cart cells||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chimeric Antigen Receptor T Cells (CART) Therapy in GUCY2C Positive Digestive System Tumors|
|Estimated Study Start Date :||March 2021|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||March 2026|
Experimental: Patients with late malignant digestive tract tumor
Patients with late malignant digestive tract tumor, for example metastatic colorectal cancer, pancreatic cancer, gastric cancer and so on. because of this is a open, single arm trail, there is no control group.
Biological: gucy2c cart cells
Patients with advanced malignant gastrointestinal tumors were injected with CART cells
- Number of participants with CAR-T treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 24 months ] [ 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.
- The event of cytokine release syndrome was reported using the grading scale in the protocol. [ Time Frame: 24 months ]We will summarize the classification of cytokine release syndrome (CRS) according to the severity and system organ classification.
- Efficacy will be assessed according to RECIST1.1 or EORTC or PERCIST criteria [ Time Frame: 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780529
|Contact: Yifu Heemail@example.com|
|Contact: Daiyan Liufirstname.lastname@example.org|
|Anhui provincial cancer hospital|
|Hefei, Anhui, China|
|Principal Investigator:||Yifu he||Anhui Provincial Cancer Hospital|