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The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery.
The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | XH001 injection administered based on adjuvant chemotherapy with the mFOLFIRINOX regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XH001 Injection | Biological | mRNA neoantigen cancer vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (based on the Criteria for the Evaluation of Adverse Events [CTCAE] v5.0) | up to 36 months |
| Dose-Limiting Toxicity | Grade 3 or higher adverse events (AEs) or laboratory abnormalities related to XH001 injection | From the first administration of XH001 to 4 weeks after the first administration of XH001 injection. |
| Immune response at different doses | Using in vitro ELISPOT and/or TCR-Clone track to verify the immunoreactivity of the peripheral blood lymphocytes from the subjects to the selected tumor neoantigens. | From Baseline up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent-Free Survival | The time from the patient undergoing radical surgery to recurrence or death from any cause, whichever comes first. | 3 years |
| Local Recurrent-Free Survival | The time from the patient undergoing radical surgery to local recurrence or death from any cause, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Zhang | Contact | 0086-18615536063 | yiz@neocura.net | |
| Bo Liu | Contact | 0086-18101388626 | bliu@neocura.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| mFOLFIRINOX Treatment Regimen |
| Drug |
oxaliplatin+lrinotecan+calcium folinate+5-FU |
|
| 3 years |
| Distant metastasis-Free Survival | The time from the patient undergoing radical surgery to distant metastasis or death from any cause, whichever comes first. If the patient has not developed metastasis by the end of the study, the last follow-up time will be the endpoint. | 3 years |
| Overall survival | The time from the patient undergoing radical surgery to death from any cause. | 3 years |
| Peking University Cancer Hospital | Recruiting | Beijing | China |
|
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D018281 | Cholangiocarcinoma |
| D005706 | Gallbladder Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005705 | Gallbladder Diseases |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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