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

July 27, 2026 updated by: Zhongyin Yang, M.D., Ph.D, Ruijin Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Huangpu District
      • Shanghai, Huangpu District, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1-year survival rate
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment related adverse events
Time Frame: 24 months
24 months
Objective response rate
Time Frame: up to 24 months
up to 24 months
Duration of Response
Time Frame: up to 24 months
Duration of Response
up to 24 months
Progressive free survival (PFS)
Time Frame: up to 36 months
up to 36 months
Overall survival (OS)
Time Frame: up to 36 months
up to 36 months
pCR rate after conversion surgery
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRAGON-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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