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The objective of this clinical trial is to compare the effects of yttrium-90 (SIRT) treatment and hepatic arterial perfusion chemotherapy (HAIC) on progression-free survival (PFS) in patients with potentially resectable HCC in the HCC population. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC | Active Comparator | After successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3~4 weeks, a total of 2 or 4 strokes. |
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| Yttrium-90 | Experimental | Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium-90 | Procedure | Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival, PFS | It is a key indicator to evaluate the "ability to delay disease progression" of cancer therapy, especially for the analysis of interim efficacy of long-survival or advanced cancers. | The time interval between the start of treatment and the time when the tumor has progressed (e.g., increase in size, metastasize) or died due to any cause, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Time (OS) | The time from initiation of treatment to death due to any cause is one of the gold standards for evaluating the effectiveness of cancer treatment. | The patient was treated for the first time until death, an average of 2 year |
| Objective Response Rate, ORR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Li | Contact | 86-19971979632 | liqiang@jnu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| HAIC | Procedure | After successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3~4 weeks, a total of 2 or 4 strokes. For details, see 3.3.1.4 Grouping and Treatment Flow Chart. After the end of HAIC, rest for 3~4 weeks for re-examination, and arrange liver resection after excluding surgical contraindications. |
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Proportion of patients whose tumor volume shrinks to pre-specified criteria (as in RECIST criteria) and remains for a certain period of time, including complete response (CR) and partial response (PR). |
| From the first time the patient is treated to the patient's follow-up for disease progression, an average of 2 year |
| Disease Control Rate, DCR | The proportion of patients achieving complete response, partial response, or stable disease (SD) reflects the ability of treatment to control tumor progression. | The patient was treated for the first time until death, an average of 2 year |
| Safety of treatment (incidence of treatment-related adverse events assessed by CTCAE Version 4.03) | The incidence and severity of treatment-related adverse reactions (such as liver injury, hematotoxicity, etc.) in the yttrium-90 group and the control group were counted to evaluate the safety of the treatment. | From the time of first treatment to the patient's death, an average of 2 year |
| Surgical resection rate | The proportion of patients treated who successfully had their tumors completely removed by surgery | The time interval from the start of treatment to death due to any cause, an average of 2 year |
| 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 |
|---|---|
| C000615496 | Yttrium-90 |
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