About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Previous receipt of claudin 18.2-targeted therapy;
Previous receipt of any drug containing a topoisomerase I inhibitor drug, including antibody-drug conjugates;
Merkel cell carcinoma, neuroendocrine prostate cancer, and medullary thyroid carcinoma;
Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. Patients who had received previous treatment for brain metastases (radiotherapy or surgery) were eligible for enrollment if they had been stable for at least 4 weeks as confirmed by imaging and had been free of systemic hormone therapy (at a dose of >10 mg per day of prednisone or the equivalent) for more than 2 weeks and were asymptomatic;
Trial design
Single group
Treatments tested in this trial
SHR-A1904 Injection
DrugSHR-A1904
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Overall Survival
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.
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.
Sponsors and contacts
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