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This is a prospective, single-arm, single-center, clinical research.This trial will explore the efficacy and safety of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.
There is no high-level evidence on the efficacy of systemic therapy in neoadjuvant studies for hepatocellular carcinoma, and guidelines recommend TACE as the treatment of choice. Given that combination therapies such as immunotherapy in combination with targeted therapy and immunotherapy in combination with chemotherapy have achieved good efficacy in systemic therapy for liver cancer, this study is intended to explore the efficacy of TACE.
In this study, we propose to explore the use of kareliozumab in combination with apatinib and oxaliplatin for the treatment of hepatocellular carcinoma.
In this study, we propose to investigate the efficacy and safety of neoadjuvant therapy with kalilizumab in combination with apatinib and oxaliplatin in patients with potentially resectable hepatocellular liver cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Apatinib Mesylate+Oxaliplatin | Experimental | An study of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | 250 mg, oral every other day. Approximately half an hour after a meal (the daily dose should be taken at the same time as possible) with warm boiled water. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response(MPR) 10% | Survival tumor ≤10% during surgery | Up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | Up to two years |
| 1-year tumor recurrence-free rate RFS | Subjects underwent radical resection from the start until the date of the first documented tumor into recurrence or death from any cause, whichever occurred first |
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Inclusion Criteria:
Hepatocellular carcinoma combined with cancerous thrombus in a branch of a grade 1 or 2 vasculature (portal vein, hepatic vein, bile duct) (imaging confirmed).
Lymph node metastasis (image confirmed). Liver tumor ≥ 5 cm; multiple tumors with ≤ 3 tumors, but located in one lobe (imaging [CT, MRI or ultrasound]) Hepatocellular carcinoma tumors located in the middle lobe (segment IV, V, VIII) or caudal lobe of the liver; hepatocellular carcinoma tumors within 1 cm of a branch of a grade 1 or 2 vasculature (portal vein, hepatic vein, bile duct) or involving the above-mentioned vasculature (expected cut edge < 1 cm).
Tumor with satellite foci or subfoci. Tumor without envelope or incomplete tumor with envelope, multi-nodal fusion. 6. NRS ≤3 points. 7. Patients who have not received any previous antineoplastic drug treatment. 8. At least 1 measurable lesion that meets RECIST 1.1 criteria. 9. Liver function Child-Pugh score: grade A-B (≤7). 10. Expected survival > 3 months. 11. Relevant indicators meet the following criteria:
13. Patients with HBV or HCV infection are required to be on antiviral therapy for the duration of the trial.
Subjects voluntarily enrolled in this study, signed informed consent, good compliance and cooperation with follow-up.
Exclusion Criteria:
- Patients will not be entered into this study if they meet any of the following criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianping Xu, Master's Degree | Contact | 13651379626 | 13651379626@139.com |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| C000631724 | camrelizumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Camrelizumab | Drug | 200 mg, 30 minutes intravenous drip (overall dosing time no shorter than 20 minutes and no longer than 60 minutes, including tube flush time) once every 2 weeks, with the first dose administered concurrently with Apatinib Mesylate Tablets. |
|
| Oxaliplatin | Drug | 85 mg/m2, once every 2 weeks, to be administered half an hour after Camrelizumab injection. |
|
| Up to one years |
| Disease free survival (DFS) | Time to disease progression or postoperative recurrence in subjects starting from radical postoperative resection, during the treatment period, and during the follow-up period | Up to two years |
| Intraoperative and postoperative complications | Including bleeding volume and prolonged hospital stay | Up to two years |