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This is a single center, multi-cohort, phase I basket trial to evaluate the safety and efficacy of camrelizumab in combination with bevacizumab and HAIC for metastatic liver cancer after standard treatment failure
For patients with advanced primary liver cancer, immunotherapy combined anti-angiogenic therapy has gradually become the first-line standard treatment. However, for metastatic liver cancer, especially after first-line treatment failure, the current treatment options are mostly systemic chemotherapy, and there is still a lack of effective treatment methods. Compared with systemic chemotherapy, HAIC has a higher objective response rate and survival rate, and the incidence of adverse reactions is lower. At the same time, PD-1 combined with chemotherapy has become the first-line standard treatment for many cancers; referring to the expert consensus on liver metastasis of solid tumors and ongoing clinical research, the "PD-1 + anti-angiogenesis + HAIC" regimen can be used as a new research direction for posterior treatment for metastatic liver cancer.
In view of the failure of first-line chemotherapy, how to find effective chemotherapy drugs has become a top priority. HAIC guided by genetic testing may be able to screen out effective chemotherapy drugs
This study is an open-label, single-center, multi-cohort, phase I basket trial designed to explore safety and efficacy of "camrelizumab + bevacizumab + HAIC guided by genetic testing" for metastatic liver cancer after standard treatment failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver metastasis of gastric cancer | Experimental | HAIC: refer to genetic test results,D1; Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of breast cancer | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of lung cancer | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of nasopharyngeal carcinoma | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of thyroid cancer | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC、Bevacizumab、Camrelizumab | Drug | HAIC: refer to genetic test results,D1 Bevacizumab:7.5mg/Kg, D2, Q3W Camrelizumab:200mg, D2, Q3W |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and degree of Adverse Events and Serious Adverse Events | Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs). | 24 months |
| ORR | objective response rate(ORR),defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | disease control rate(DCR), defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator | 24 months |
| PFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Tan | Contact | 15800680751 | 121176421@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Wang | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200062 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Liver metastasis of melanoma | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of stromal tumor | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of sarcoma | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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| Liver metastasis of other solid tumor | Experimental | HAIC: refer to genetic test results,D1;Bevacizumab:7.5mg/Kg, D2, Q3W;Camrelizumab:200mg, D2, Q3W; |
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progression-free survival(PFS), defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
| 24 months |
| OS | overall survival(OS), defined as the time from enrollment to death due to any cause. | 24 months |
| D008107 |
| Liver Diseases |