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 | Recruiting Phase 2 DMC

• 1 other identifier: DRAGON-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Peritoneal Metastases; Gastric Cancer Stage IV

Keywords

Gastric cancer; Peritoneal metastasis; Cadonilimab; Claudin 18.2; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• 1-year survival rate

  up to 24 months

Secondary Outcomes (6)

• treatment related adverse events

  24 months

• Objective response rate

  up to 24 months

• pCR rate after conversion surgery

  up to 24 months

• Duration of Response

  up to 24 months

• Progressive free survival (PFS)

  up to 36 months

Study Arms (1)

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

Interventions

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

Experimental

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 adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
• Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;
• Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
• Age ≥ 18 years at registration;
• Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
• Expected life expectancy \> 3 months;
• Adequate bone marrow, liver, and renal functions.

You may not qualify if:

• Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
• During pregnancy, within 28 days of post parturition, or during lactation;
• Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
• Synchronous or metachronous (within 5 years) malignancies.
• Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
• 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;
• Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
• Known peripheral neuropathy (\> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;
• Patients on steroid or immunosuppressant treatment after organ transplant;
• Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;
• Moderate or severe renal damage \[creatinine clearance ≤ 50 ml/min\], or serum creatinine \> upper limit of normal (ULN), 115 μmol/L;
• Known dihydropyrimidine dehydrogenase (DPD) deficiency;
• Anaphylaxis to paclitaxel or any research drug ingredient.
• Active autoimmune disease or history of refractory autoimmune disease;
• Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;

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, PhD

CONTACT

8621-64370045; jeffreyyong@163.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: February 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)