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

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Gastric Cancer Stage IV; Peritoneal Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cadonilimab, LM-302, S-1, paclitaxel

Intervention Type: DRUG

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.

Interventions

Cadonilimab, 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.

Intervention Type: DRUG

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. At least one measurable lesion, according to RECIST v1.1 as assessed by the investigator.

8. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

YANGZHONGYIN

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu District, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongyin Yang, PhD

Role: CONTACT

jeffreyyong@163.com

8621-64370045

Facility Contacts

Zhongyin Yang, PhD

Role: primary

jeffreyyong@163.com

862164370045

Other Identifiers

DRAGON-12

Identifier Type: -

Identifier Source: org_study_id