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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05213767
Eligibility Criteria:
Inclusion Criteria:
* 1 Subjects with advanced malignant tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
* 2 18-75 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.
* 3 The function of main organs is normal.
* 4 Subjects must need to adopt effective methods of contraception.
* 5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
Exclusion Criteria:
* 1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved R0 resection without recurrence and metastasis. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
* 2 The toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (Common Terminology Criteria for Adverse Events (CTCAE) 5.0).
* 3 Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before treatment.
* 4 Subjects had an arteriovenous thrombosis event within 6 months.
* 5 Subjects occurred Evans syndrome within 3 months.
* 6 History of drug abuse, alcohol or drug abuse or mental disorder.
* 7 Subjects who suffered from Active tuberculosis within 1 year.
* 8 The subjects had any history of bleeding or coagulopathy.
* 9 Cirrhosis, active hepatitis.
* 10 The subjects was diagnosed with renal failure and required hemodialysis or peritoneal dialysis.
* 11 History of immunodeficiency, including positive human immunodeficiency virus (HIV) test or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
* 12 Subjects who have epilepsy and require treatment.
* 13 Received the treatment of proprietary Chinese medicines with anti-tumor indications clearly stated in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks of starting treatment.
* 14 The symptoms of subjects with known central nervous system metastasis, spinal cord compression, meningeal metastasis, or leptomeningeal disease.
* 15 Vaccination history of live attenuated vaccine before 28 days of starting treatment, or planned vaccination of live attenuated vaccine during the study period.
* 16 History of severe allergy to macromolecule drugs or known components of TQB2916 injection.
* 17 Receiving any other investigational agent within 4 weeks before first dose.
* 18 According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05213767
Study Brief:
Protocol Section:
NCT05213767