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For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows:
First, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy combined with tislelizumab and anlotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy combined with tislelizumab and anlotinib | Combination Product | Radiotherapy was performed using conventional fractionation. The PTV of the primary tumor and portal vein tumor thrombus was DT45-50Gy/25f, and the GTV was simultaneously pushed at DT50-60Gy/25f, Tislelizumab 200mg IV Q3W Anlotinib 12MG PO QD for two weeks followed by a one-week break Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The proportion of patients whose tumor volume has shrunk by more than 20% and can be maintained for more than 4 weeks. | The time from the start of the first medication to the occurrence of tumor shrinkage or disappearance and maintaining it for more than 4 weeks (up to 36 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | up to 36 months | |
| Progression-Free Survival | up to 36 months | |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jinxue Zhou | Contact | +86 13837175001 | zhoujx888@126.com |
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|
The percentage of patients whose tumors shrank or remained stable over a period of time.
| up to 36 months |
| Duration of response | up to 36 months |
| Surgical resection rate | After the treatment of portal vein tumor thrombus downstaging, the researchers evaluated that surgical resection was feasible, which was considered a successful transformation. The proportion of those who ultimately underwent resection was the conversion rate of surgical resection. | up to 36 months |
| adverse event | Any adverse medical event that occurs to a patient or clinical trial subject after receiving a certain drug, but it does not necessarily have a causal relationship with the treatment. | From the first treatment to 30 days after the end of the study |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| C000625192 | anlotinib |
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