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

NCT07556640 | Recruiting Phase 2 DMC

• 1 other identifier: DRAGON-17
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer Stage IV; Peritoneal Metastases From Gastric Cancer; Gastric or Esophagogastric Junction Adenocarcinoma

Keywords

Gastric cancer; Peritoneal metastasis; Claudin 18.2; Cadonilimab; Paclitaxel; Gastric or Esophagogastric Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year survival rate

  up to 24 months

Secondary Outcomes (6)

• treatment related adverse events

  up to 24 months

• Progressive free survival (PFS)

  up to 36 months

• Overall survival (OS)

  up to 36 months

• Disease control rate (DCR)

  up to 24 months

• Objective response rate (ORR)

  up to 24 months

Study Arms (2)

LM-302 and S-1 Plus Intraperitoneal Paclitaxel

EXPERIMENTAL

Drug: LM-302, S-1, paclitaxel

LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab

ACTIVE COMPARATOR

Drug: LM-302, Cadonilimab, S-1, paclitaxel

Interventions

LM-302, S-1, paclitaxel DRUG

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.

LM-302 and S-1 Plus Intraperitoneal Paclitaxel

LM-302, Cadonilimab, S-1, paclitaxel DRUG

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.

LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Huangpu District, 200025, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Zhongyin Yang

CONTACT

8621-64370045; jeffreyyong@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 29, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)