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New treatment option for Gastric Cancer Stage IV
Official title Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis
ClinicalTrials.gov ID: NCT06519591
What this study is testing
What is Cadonilimab, LM-302, S-1, paclitaxel?
Cadonilimab, 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 phase 2 study, we combined Cadonilimab, LM-302, and S-1 combined with intraperitoneal infusion of paclitaxel as regimen to treat gastric cancer patients 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 adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
- Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal...
- Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
- Age ≥ 18 years at registration;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
You likely can't join if
- Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node...
- During pregnancy, within 28 days of post parturition, or during lactation;
- Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
- Synchronous or metachronous (within 5 years) malignancies.
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
- Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe...
See the full eligibility criteria
- Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
- Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;
- Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
- Age ≥ 18 years at registration;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
- Expected life expectancy \> 3 months;
- Adequate bone marrow, liver, and renal functions.
- Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
- During pregnancy, within 28 days of post parturition, or during lactation;
- Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
- Synchronous or metachronous (within 5 years) malignancies.
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
- Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or...
- Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
- Known peripheral neuropathy (\> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;
- Patients on steroid or immunosuppressant treatment after organ transplant;
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;
- Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine \> upper limit of normal (ULN), 115 μmol/L;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Anaphylaxis to paclitaxel or any research drug ingredient.
- Active autoimmune disease or history of refractory autoimmune disease;
- people with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
- HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);
- Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids...
- Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Huangpu District, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.