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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Zhongyin Yang, PhD
jeffreyyong@163.com
8621-64370045
Time Frame
Start Date: 2024-07
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
Experimental: Experimental
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.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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