Treatment for advanced gastric cancer with peritoneal metastasis using a combination of therapies

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

This study is testing a new combination of treatments for people with advanced gastric cancer that has spread to the abdomen to see if it can help slow down the disease and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: immunotherapy, prednisone, Cadonilimab
• Locations: 1 site (Shanghai, Huangpu District)
• Trial ID: NCT06519591 on ClinicalTrials.gov

What this trial studies

This phase 2 study investigates the efficacy of a treatment regimen combining Cadonilimab, LM-302, and S-1 with intraperitoneal infusion of paclitaxel for patients with Claudin 18.2-positive gastric cancer that has spread to the peritoneum. The approach aims to target specific cancer markers and enhance treatment effectiveness. Participants will receive these therapies to assess their impact on disease progression and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed gastric adenocarcinoma that is Claudin 18.2 positive and has peritoneal metastases.

Not a fit: Patients with distant metastases beyond the peritoneum or those who have previously received certain immunotherapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastric cancer and peritoneal metastasis.

How similar studies have performed: While there is ongoing research in this area, the specific combination of therapies in this study represents a novel approach to treating this condition.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
2. Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;
3. Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
4. Age ≥ 18 years at registration;
5. Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
6. Expected life expectancy \> 3 months;
7. Adequate bone marrow, liver, and renal functions.

Exclusion Criteria:

1. Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
2. During pregnancy, within 28 days of post parturition, or during lactation;
3. Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
4. Synchronous or metachronous (within 5 years) malignancies.
5. Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
6. 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 a history of myocardial infarction in the last 12 months;
7. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
8. Known peripheral neuropathy (\> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;
9. Patients on steroid or immunosuppressant treatment after organ transplant;
10. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;
11. Moderate or severe renal damage \[creatinine clearance ≤ 50 ml/min\], or serum creatinine \> upper limit of normal (ULN), 115 μmol/L;
12. Known dihydropyrimidine dehydrogenase (DPD) deficiency;
13. Anaphylaxis to paclitaxel or any research drug ingredient.
14. Active autoimmune disease or history of refractory autoimmune disease;
15. Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
16. 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);
17. 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 of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;
18. Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.

Where this trial is running

Shanghai, Huangpu District

• Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Huangpu District, China (Recruiting)

Study contacts

• Study coordinator: Zhongyin Yang, PhD

Conditions Gastric Cancer Stage IV; Peritoneal Metastases; Gastric cancer; Peritoneal metastasis; Cadonilimab; Claudin 18.2; Paclitaxel