Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Investigational drug(s) / intervention(s)
LM-302ApatinibIrinotecan
LM-302: LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
Apatinib: The subjects will receive Apatinib orally,qd
Irinotecan: The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle
Study summary
This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Overall Survival (OS) — up to 42 months OS was defined defined as the time from date of randomization until death from any cause.
Progression Free Survival (PFS) — up to 42 months PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
Trial sites (2)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Shanghai East Hospital
Shanghai
Shanghai Municipality
More LaNova Medicines Zhejiang Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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