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The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1826 monotherapy arm | Experimental |
| |
| SHR-1826 and immunotherapy combination therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1826 | Drug | SHR-1826 will be administrated per dose level in which the patients are assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by RECIST V1.1 | The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1. | up 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by mRECIST | The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST. | up 2 years |
| Disease control rate (DCR) by RECIST V1.1 | The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD). |
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Inclusion Criteria:
1.18-75 years old, male or female.
2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;
3.Failure of at least one line of standard treatment (progression or intolerance);
4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);
5.Expected survival time ≥ 12 weeks;
6.Normal function of major organs;
7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoming Shi, M.D | Contact | 13916969578 | shi.guoming@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | 200020 | China |
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| SHR-1826 and immunotherapy combination therapy | Drug | SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned. |
|
| up 2 years |
| Progression-free survival (PFS) | The PFS is defined as Time from the date of enrollment to of disease. | up 2 years |
| Overall survival (OS) | The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. | up 2 years |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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