RecruitingPhase 2NCT06519591

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


Sponsor

Ruijin Hospital

Enrollment

40 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of four cancer drugs — including immunotherapy (cadonilimab), an antibody-drug conjugate (LM-302), an oral chemotherapy (S-1), and a chemotherapy given into the belly (paclitaxel) — for people with stomach cancer that has spread to the lining of the abdomen and tests positive for a protein called Claudin 18.2. **You may be eligible if...** - You are 18 or older - You have confirmed stomach (gastric) adenocarcinoma that is HER2-negative and Claudin 18.2 positive - The cancer has spread to the peritoneum (abdominal lining) confirmed by laparoscopy - You have not had surgery to remove the stomach tumor or metastases - You are in reasonably good health (ECOG score 0 or 1) - Your life expectancy is more than 3 months **You may NOT be eligible if...** - The cancer has spread beyond the abdomen (e.g., to the liver or lungs) - You previously received immunotherapy (PD-1/PD-L1) or Claudin 18.2 targeted therapy - You are pregnant, recently gave birth, or are breastfeeding - You have severe heart disease, kidney problems, or active autoimmune disease - You have bowel obstruction or nerve damage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab, LM-302, S-1, paclitaxel

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.


Locations(1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu District, China

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NCT06519591


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