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This is a prospective, single-center, phase II trial designed to evaluate the efficacy and safety of SHR-A1904 monotherapy in second-line or later treatment of advanced neuroendocrine carcinoma. The primary endpoint is the objective response rate. Secondary endpoints include progression free survival, overall survival rate, duration of response, disease control Rate and adverse event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The Treatment group receive SHR-A1904 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1904 Injection | Drug | SHR-A1904 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment. | Screening up to study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival measures the length of time during and after treatment that a patient lives with the disease. without it progressing. | Screening up to study completion, an average of 2 year |
| Overall Survival |
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Inclusion Criteria:
Willing to join in this study, signed informed consent, good adherence, can cooperate with the follow-up;
Age 18-75 years old, both genders;
Patients with histologically confirmed advanced neuroendocrine carcinoma;
Progressed form previous standard therapy (at least progressed form the first line of platinum-based chemotherapy);
Tumor tissue samples (within 2 years or freshly obtained) must be available.
At least one measurable lesion that met RECIST v1.1 criteria. Measurable lesions must not have received prior local therapy such as radiotherapy;
ECOG Performance Status of 0-1;
Must have life-expectancy of ≥ 12 weeks;
Adequate function of marrow and major organs meets the following requirements:
Female patients of childbearing age or male patients whose partner was a female of childbearing age had to consent to use a highly effective method of contraception for the duration of the study and for 6 months after the last dose of study drug; and have no plans to have children or to donate sperm or eggs, Childbearing age female patients who were not surgically sterilized had to undergo a serum pregnancy test with a negative result within 7 days before starting study treatment.ï¼›
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Lu, MD | Contact | +86-10-88196561 | qiminglu_mail@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 100142 | China |
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Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.
| Screening up to study completion, an average of 2 year |
| Disease control rate | Disease control rate refers to the proportion of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable disease (SD) cases. | Screening up to study completion, an average of 2 year |