LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study

April 24, 2026 updated by: Zhongyin Yang, MD., PhD, Ruijin Hospital

LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis: a Prospective, Exploratory Study

In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

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:

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
  • Age ≥ 18 years at registration;
  • Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;
  • Claudin 18.2 positive (≥ 25%, moderate to strong staining);
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
  • Expected life expectancy > 3 months;
  • Adequate bone marrow, liver, and renal functions.

Exclusion Criteria:

  • Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
  • Pregnant or breastfeeding women;
  • Prior treatment with Claudin 18.2 targeted therapy;
  • History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
  • History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing informed consent or compliance with oral medication.
  • Clinically significant active heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medication, or myocardial infarction within the past 12 months;
  • Upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect S 1 absorption;
  • Known peripheral neuropathy ≥ NCI CTC AE grade 1. However, patients with loss of deep tendon reflexes (DTR) alone may be included;
  • Organ transplantation requiring immunosuppressive therapy;
  • Severe uncontrolled recurrent infection or other severe uncontrolled concomitant diseases;
  • Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min) or serum creatinine above the upper limit of normal;
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency;
  • Active hepatitis (for hepatitis B: HBsAg positive and HBV DNA ≥ 500 IU/ml; for hepatitis C: HCV antibody positive and HCV viral load > upper limit of normal);
  • Psychiatric disorder that makes the patient unable to comply with treatment;
  • Allergy to paclitaxel or any component of the study drugs;
  • History or evidence of any disease, condition, treatment, or laboratory abnormality that could interfere with the study results or the patient's full participation, or any other condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LM-302 and S-1 Plus Intraperitoneal Paclitaxel
Drug: LM-302, S-1, paclitaxel
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: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.
Active Comparator: LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab
Drug: LM-302, Cadonilimab, S-1, paclitaxel
LM-302 2.0 mg/kg, Cadonilimab 10mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.

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
Overall survival (OS)
Time Frame: up to 36 months
up to 36 months
treatment related adverse events
Time Frame: up to 24 months
up to 24 months
Progressive free survival (PFS)
Time Frame: up to 36 months
Progression-free survival (PFS) is defined as the time from enrollemnt to disease progression or death from any cause.
up to 36 months
Disease control rate (DCR)
Time Frame: up to 24 months
up to 24 months
Objective response rate (ORR)
Time Frame: up to 24 months
ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1 criteria.
up to 24 months
Major Pathological Response (MPR) rate
Time Frame: up to 24 months
Defined as tumor specimens resected after conversion surgery with residual tumor cells ≤10%
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)

April 17, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRAGON-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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