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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06519591•Ruijin Hospital

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+8 more criteria

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu District, China

Key Dates

Start Date

February 25, 2025

Primary Completion Date

May 1, 2026

Completion Date

December 1, 2026

Last Updated

February 18, 2026

Enrollment

ESTIMATED participants

Conditions

Gastric Cancer Stage IVPeritoneal Metastases

Interventions

Cadonilimab, LM-302, S-1, paclitaxel

DRUG

Contacts

Zhongyin Yang, PhD

CONTACT

8621-64370045 jeffreyyong@163.com

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

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COMPLETEDPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

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