Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05973968
Eligibility Criteria:
Inclusion Criteria:
1. Have fully understood this study and voluntarily signed the informed consent form;
2. Age ≥ 18 years old, both male and female;
3. Neuroendocrine tumors diagnosed by histopathology or cytology (patients with neuroendocrine tumors diagnosed as G3 according to WHO2019 criteria, and Ki67 index ≤ 55%);
4. Progress after at least one systemic chemotherapy;
5. According to the evaluation criteria of solid tumor efficacy (RECISTV1.1), there is at least one measurable lesion.
6. Palliative radiotherapy at the localized site was allowed for more than 7 days since the end of the last systematic treatment, which has been over 4 weeks.
7. Expected survival ≥ 12 weeks;
8. The researchers assessed that they could benefit;
9. Have enough organ and bone marrow function;
10. Fertile male or female patients voluntarily used effective contraceptive methods during the study period and within 6 months of the last study, such as double barrier contraceptives, condoms, oral or injection contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation). Otherwise, the serum of female patients showed that they were not pregnant within 7 days before the study and must be non-lactation patients.
Exclusion Criteria:
1. Other malignant tumors have been diagnosed in the past 5 years, except for skin basal cell carcinoma, skin squamous cell carcinoma, cervical cancer in situ and breast cancer after effective treatment.
2. At the same time, receive other experimental drugs or approved or under research anti-tumor therapy;
3. Patients with contraindications of Surufatinib (such as active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrollable hypertension, III-IV cardiac insufficiency, severe hepatic and renal insufficiency within 30 days after major operation, etc.).
4. The patient currently has any disease or condition that affects drug absorption, or the patient cannot take Surufatinib orally;
5. It has been proved to be allergic to experimental drugs and any components in their excipients;
6. Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding;
7. Patients with large pleural effusion or ascites need drainage;
8. Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the findings or put the patient at high risk;
9. Drugs containing Hypericum perforatum were taken within 3 weeks before treatment, or other strong inducers or inhibitors of CYP3A4 were taken in the previous 2 weeks.
10. According to the researchers, the subjects have other factors that may lead to the termination of this study or are not suitable for inclusion, such as other serious concomitant diseases (such as severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, mental illness), severe laboratory abnormalities, family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05973968
Study Brief:
Protocol Section:
NCT05973968