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Tests treatment safety and results for Adenocarcinoma
Official title Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.
ClinicalTrials.gov ID: NCT07385703
What this study is testing
What is LM-302 Injection?
LM-302 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.
- Age ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any...
- Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination...
You likely can't join if
- Other pathological types confirmed by histopathology, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
- There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels...
- Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged...
- Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of...
- Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for...
- Accompanied by severe peritoneal metastasis, the main manifestations are: clinically significant intestinal obstruction; barium enema indicating...
See the full eligibility criteria
Who can join
- Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.
- Age ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment:
- Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or...
- The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to...
- Archived specimens or fresh tumor tissue specimens from ≤3 years ago must be provided for CLDN18.2 and PD-L1 testing (PD-L1 results are not a condition for enrollment). When multiple samples are present, the most recent...
- A negative report on the expression detection of human epidermal growth factor receptor-2 (HER2) in tumor tissue must be provided. The definition of HER2 negative expression is ImmunoHistoChemistry (IHC) score 0/1+, IHC...
- According to the RECIST 1.1 evaluation criteria, there must be at least one measurable lesion.
- Expected survival duration ≥ 3 months.
- According to the Eastern Cooperative Oncology Group (ECOG) standards, the physical performance status score is 0 or 1.
- Good organ function: a. Bone marrow reserve: Platelets (PLT) ≥ 100×10\^9/L, absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or supportive treatment such as...
- Women of childbearing age must have a negative blood pregnancy test within 7 days before administration; any fertile male and female people must agree to use highly effective contraception throughout the study...
What rules you out
- Other pathological types confirmed by histopathology, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
- There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels, and are assessed by the researchers as posing a high risk of major...
- Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged by the investigator to have stable brain metastases can be enrolled...
- Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of intestinal obstruction or paralysis, compartmented ascites, undergoing or...
- Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for patients with previously diagnosed and treated spinal cord...
- Accompanied by severe peritoneal metastasis, the main manifestations are: clinically significant intestinal obstruction; barium enema indicating small intestinal stenosis.
- History of gastrointestinal perforation or gastrointestinal fistula within the previous 6 months. If the perforation or fistula has been treated through resection or repair surgery, and the condition is assessed by the...
- Poorly controlled tumor-related pain:
- For patients requiring analgesic treatment, a stable dosage of treatment must be established before participating in the study.
- Symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastasis causing nerve damage) should be treated before enrollment.
- Before enrollment, if appropriate, consideration should be given to local treatment for asymptomatic metastatic lesions that may lead to functional deficits or intractable pain due to further growth (e.g., epidural...
- Patients with a body weight of less than 35kg or a body weight loss of more than 10% within 2 months prior to signing the informed consent form. Exclusion criteria for comorbidities or concomitant conditions:
- History of malignancy other than Gastric Cancer (GC)/GastroEsophageal Junction adenocarcinoma (GEJ) adenocarcinoma within 2 years prior to randomization, with the following exceptions: basal cell carcinoma of the skin...
- History of autoimmune diseases, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- people with type 1 diabetes who are well-controlled under a stable insulin treatment regimen.
- Only people with skin autoimmune diseases that do not require systemic treatment (such as vitiligo, alopecia, psoriasis, or eczema).
- people who have recovered from childhood asthma and do not require any intervention in adulthood.
- people whose relevant diseases, as assessed by the researchers, are unlikely to recur without external triggers.
- Patients who have previously undergone allogeneic bone marrow transplantation or solid organ transplantation.
- Patients with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, left bundle branch block, prolonged QRS complex, etc.;
- Patients with thromboembolic events requiring therapeutic anticoagulation, or those with venous filters;
- Patients with heart failure of New York Heart Association (NYHA) class III or IV;
- Patients who have experienced acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular and cerebrovascular events of grade 3 or above within the previous 6 months prior to...
- Have a history of myocarditis or cardiomyopathy.
- For individuals infected with human immunodeficiency virus (HIV) and those with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the following conditions are allowed for enrollment: Patients who are...
- people with known active syphilis infection.
- Individuals who are unable to control themselves or have severe illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks before the first dose, and interstitial...
- people with known active tuberculosis. For patients suspected of having active tuberculosis, a comprehensive evaluation should be conducted based on chest imaging, sputum smear/culture, or molecular testing results, as...
- Currently present peripheral sensory or motor neuropathy of ≥ grade 2.
- people who received systemic corticosteroids (\>10mg/d prednisone equivalent) or other systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor...
- Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed;
- Patients receiving acute low-dose systemic immunosuppressive drugs (e.g., single-dose dexamethasone for nausea);
- Patients requiring baseline and subsequent MRI/CT tumor assessments who have previously experienced allergic reactions to intravenous contrast agents may receive prophylactic steroids;
- Inhaled corticosteroids are allowed for the treatment of chronic obstructive pulmonary disease, hydrocortisone for the treatment of orthostatic hypotension, and low-dose corticosteroid hormone maintenance therapy for...
- There are factors that affect the application and absorption of oral medications, such as dysphagia, clinically uncontrollable persistent and recurrent vomiting (such as caused by gastric outlet obstruction), intestinal...
- The adverse reactions from previous anti-tumor treatment within the 14 days prior to randomization have not yet recovered to a level of ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE)...
- Have a history of allergy to LM-302, Ticagrelor, any control drug, or its excipients.
- Individuals with known mental illnesses or disorders that may affect trial compliance. Exclusion criteria related to drug treatment:
- Within 28 days prior to randomization, the subject is currently participating or has previously participated in any investigational drug study, or has used an investigational device within 28 days. people who have...
- Previously received targeted therapy targeting CLDN18.2, such as antibody-drug conjugate (ADC) therapy, antibody therapy, and chimeric antigen receptor T-cell (CAR-T) therapy; previously received ADC therapy using small...
- people who have received palliative local treatment (such as radiotherapy or surgery) for non-target lesions within 2 weeks prior to the first dose, or who have previously received radiotherapy for locally advanced...
- Within the first 2 weeks before randomization, patients received systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications, or with Chinese herbal medicine, or with...
- Having undergone or planning to undergo major surgery or treatment therapy (excluding tumor biopsy, puncture, etc.) within the 28 days prior to randomization or during the study period.
- Use of strong inhibitors/strong inducers of CYP3A4 within 14 days before randomization;
- Vaccination with any live vaccine or attenuated live vaccine within 28 days before randomization.
- Other situations where the researcher deems it inappropriate for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Wuwei, Gansu, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Shantou, Guangdong, China
- Guigang, Guangxi, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Zunyi, Guizhou, China
- Haikou, Hainan, China
- Chengde, Hebei, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Jiamusi, Heilongjiang, China
+ 39 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China and 53 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.