Phase
Condition
Adenocarcinoma
Treatment
Apatinib
Irinotecan
LM-302
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-80 years old, male and female
Has histopathologically confirmed unresectable locally advanced or metastaticadenocarcinoma 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 relapseis defined as the first line therapy.
Centrally confirmed CLDN18.2-positive
HER2 negative
At least one measurable lesion according to the solid tumor response EvaluationCriteria (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
Exclusion Criteria:
Within the first 5 years of randomization, there is a history of malignant tumorsother than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervicalcarcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma thathave been cured and cured after treatment
Individuals with a history of previous immunodeficiency, including those with otheracquired or congenital immunodeficiency diseases, or those with a history of organtransplantation, allogeneic bone marrow transplantation, or autologous hematopoieticstem 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 notlimited to active infections requiring systemic antibiotic treatment within 2 weeksprior to initial medication, interstitial pneumonia/lung disease requiringintervention during screening, and tumor related pain requiring local treatmentduring 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 periodwithin the first 28 days of randomization
The researcher determined that there are other situations that are not suitable forparticipation in this study
Study Design
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
Shanghai East Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
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