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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06351020
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years old, male and female
* Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
* Has received and progressed on at least 2 lines of systemic therapy. A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy.
* Centrally confirmed CLDN18.2-positive
* HER2 negative
* At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1)
* ECOG: 0-1
* Expected survival ≥12 weeks;
* Good blood reserve and liver, kidney and coagulation function
* Willing to provide informed consent for study participation.
Exclusion Criteria:
* Within the first 5 years of randomization, there is a history of malignant tumors other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment
* Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation
* Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\>1g
* Individuals with a history of severe cardiovascular and cerebrovascular diseases
* Individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening
* Current peripheral sensory or motor neuropathy ≥ grade 2
* Uncontrollable third space effusion in clinical practice
* Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization
* The researcher determined that there are other situations that are not suitable for participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06351020
Study Brief:
Protocol Section:
NCT06351020