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This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors.
This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors. In this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required, and the specific number of infusion and the composition of the peptide pool are determined by the investigator based on clinical needs and test results. After the cells have been transfused, their safety is examined first, and their effectiveness is evaluated during follow-up. According to the needs, this study plans to enroll about 20-200 patients with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, and breast cancer. If the disease progresses during treatment, it is evaluated comprehensively by the investigator according to the clinical situation to determine whether the patient can be withdrawn from the study. Study participants in the follow-up phase who develop disease progression, begin other anti-tumor therapy without reaching disease progression after infusion, and voluntarily request to withdraw from the follow-up phase will be withdrawn from the follow-up phase and will be followed for survival only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Biological: DC-CTL DC combined with CTL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor polypeptide pool induced DC-CTL cell injection | Biological | In this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival time | From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| OS | over all survival time | From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Zhao, PhD | Contact | 0371-63290608 | revogene@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, professor | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
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