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

Trial 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

NCT ID: NCT06519591

Condition: Gastric Cancer Stage IV
Peritoneal Metastases

Conditions: Official terms:
Neoplasm Metastasis
Stomach Neoplasms
Paclitaxel

Conditions: Keywords:
Gastric cancer
Peritoneal metastasis
Cadonilimab
Claudin 18.2
Paclitaxel

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cadonilimab, LM-302, S-1, paclitaxel
Description: Cadonilimab 10mg/kg, LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks.
Arm group label: Experimental

Summary: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Status: Recruiting

Contact:
Last name: Zhongyin Yang, PhD

Phone: 862164370045
Email: jeffreyyong@163.com

Start date: July 2024

Completion date: June 2026

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06519591