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New treatment option for Gastric Cancer Stage IV
Official title LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study
ClinicalTrials.gov ID: NCT07556640
What this study is testing
What is LM-302, S-1, paclitaxel?
LM-302, S-1, paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer stage iv.
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
- In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.
- Phase 2: a mid-size study of how well it works
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
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or...
- Age ≥ 18 years at registration;
- Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal...
- Claudin 18.2 positive (≥ 25%, moderate to strong staining);
- Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
You likely can't join if
- Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
- Pregnant or breastfeeding women;
- Prior treatment with Claudin 18.2 targeted therapy;
- History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
- History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing...
- Clinically significant active heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher...
See the full eligibility criteria
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
- Age ≥ 18 years at registration;
- Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;
- Claudin 18.2 positive (≥ 25%, moderate to strong staining);
- Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
- Expected life expectancy \> 3 months;
- Adequate bone marrow, liver, and renal functions.
- Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
- Pregnant or breastfeeding women;
- Prior treatment with Claudin 18.2 targeted therapy;
- History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
- History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing informed consent or compliance with oral medication.
- Clinically significant active heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medication, or...
- Upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect S 1 absorption;
- Known peripheral neuropathy ≥ NCI CTC AE grade 1. However, patients with loss of deep tendon reflexes (DTR) alone may be included;
- Organ transplantation requiring immunosuppressive therapy;
- Severe uncontrolled recurrent infection or other severe uncontrolled concomitant diseases;
- Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min) or serum creatinine above the upper limit of normal;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Active hepatitis (for hepatitis B: HBsAg positive and HBV DNA ≥ 500 IU/ml; for hepatitis C: HCV antibody positive and HCV viral load \> upper limit of normal);
- Psychiatric disorder that makes the patient unable to comply with treatment;
- Allergy to paclitaxel or any component of the study drugs;
- History or evidence of any disease, condition, treatment, or laboratory abnormality that could interfere with the study results or the patient's full participation, or any other condition that, in the investigator's...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Huangpu District, China
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 Shanghai, Huangpu District, China. 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.