Recruiting NCT07556640
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LM-302, S-1, paclitaxel, LM-302, Cadonilimab, S-1, paclitaxel.
- Who it may be relevant to
- Registry conditions: Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- 1-year survival rate [Time frame: up to 24 months]
Secondary outcome measures (6)
- treatment related adverse events [Time frame: up to 24 months]
- Progressive free survival (PFS) [Time frame: up to 36 months]
- Overall survival (OS) [Time frame: up to 36 months]
- Disease control rate (DCR) [Time frame: up to 24 months]
- Objective response rate (ORR) [Time frame: up to 24 months]
- Major Pathological Response (MPR) rate [Time frame: up to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07556640 · DRAGON-17