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| Name | Class |
|---|---|
| NeoCura | INDUSTRY |
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The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastrointestinal cancer in adults. It will also learn if the combined treatment works to treat advanced gastrointestinal cancer.The main questions it aims to answer are:What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor neoantigen vaccine and tumor vaccine-induced specific T-cell Arm 1 | Experimental | Tumor neoantigen vaccine; Tumor vaccine-induced specific T-cell Dose 1 |
|
| Tumor neoantigen vaccine and tumor vaccine induced specific T-cell Arm 2 | Experimental | Tumor neoantigen vaccine; Tumor vaccine induced specific T-cell dose 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XH001 injection | Drug | mRNA tumor neoantigen vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Incidence and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE] V5.0 | 12 months |
| Dose Limiting Toxicity | Safety events occurring within 28 days after the reinfusion of neoantigen vaccine-induced tumor-specific T cells and related to this cell therapy. | From reinfusion of neoantigen vaccine-induced tumor-specific T cells to 28 days after the reinfusion |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | 24 months |
| PFS | Progression-Free Survival | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changsong Qi, MD | Contact | 0086-15143214682 | xiwangpku@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gobroad Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37165196 | Background | Rojas LA, Sethna Z, Soares KC, Olcese C, Pang N, Patterson E, Lihm J, Ceglia N, Guasp P, Chu A, Yu R, Chandra AK, Waters T, Ruan J, Amisaki M, Zebboudj A, Odgerel Z, Payne G, Derhovanessian E, Muller F, Rhee I, Yadav M, Dobrin A, Sadelain M, Luksza M, Cohen N, Tang L, Basturk O, Gonen M, Katz S, Do RK, Epstein AS, Momtaz P, Park W, Sugarman R, Varghese AM, Won E, Desai A, Wei AC, D'Angelica MI, Kingham TP, Mellman I, Merghoub T, Wolchok JD, Sahin U, Tureci O, Greenbaum BD, Jarnagin WR, Drebin J, O'Reilly EM, Balachandran VP. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature. 2023 Jun;618(7963):144-150. doi: 10.1038/s41586-023-06063-y. Epub 2023 May 10. |
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| Tumor vaccine-induced specific T-cell injection | Drug | Adoptive T Cell Therapy |
|
| DCR | Disease Control Rate | 24 months |
| OS | Overall Survival | 36 months |
| BOR | Best Overall Response | 24 months |
| DOR | Duration of Response | 24 months |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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