A Phase II Clinical Study of SHR-A1904 Monotherapy in Second-Line or Later Treatment of Advanced Neuroendocrine Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • SHR-A1904 Injection

    Drug

    SHR-A1904

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Screening up to study completion, an average of 2 year

Secondary outcomes

1

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.

Time frame
Screening up to study completion, an average of 2 year
2

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.

Time frame
Screening up to study completion, an average of 2 year
3

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.

Time frame
Screening up to study completion, an average of 2 year

Other outcomes

Sponsors and contacts

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