Actively Recruiting
The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Shanghai Zhongshan Hospital · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
CONDITIONS
Official Title
The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate and sign informed consent
- Have unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed as simple adenocarcinoma
- If previously treated with adjuvant or neoadjuvant therapy, have experienced disease progression at least 6 months after last treatment
- Positive for CLDN18.2 expression (≥10%) confirmed by immunohistochemistry
- Have at least one measurable lesion according to RECIST v1.1
- ECOG physical status of 0 or 1
- Expected survival more than 3 months
- Adequate kidney function with creatinine ≤1.5 times upper limit of normal and GFR ≥60 mL/min/1.73 m2
- Adequate liver function with total bilirubin ≤1.5 times ULN, AST and ALT ≤2.5 times ULN (or ≤5 times ULN if liver metastasis present)
- Adequate bone marrow function with platelet count ≥100×109/L, absolute neutrophil count ≥1.5×109/L, hemoglobin ≥9 g/dL
- No recent use of adjuvant therapies affecting blood counts or recent blood transfusions as specified
- Male or female aged 18 years or older
You will not qualify if you...
- HER2 positive gastric or gastroesophageal junction adenocarcinoma
- Major surgery or radiation therapy within 4 weeks before enrollment
- Active or suspected autoimmune diseases
- Congestive heart failure or symptomatic coronary artery disease within past 3 months
- Stroke within past 6 months
- Significant bleeding or thromboembolic events within past 6 months
- History of intestinal perforation
- History or current pneumonia requiring steroid treatment
- Known HIV infection or active hepatitis B or C not controlled by antiviral therapy
- Severe lung impairment or interstitial lung disease
- Other active malignant tumors diagnosed within past 2 years except certain treated cancers
- Conditions or treatments that could interfere with study participation or results
- Positive pregnancy test within 7 days before first treatment or breastfeeding women
- Known mental illness affecting compliance
- Recent use of systemic corticosteroids or immunosuppressive drugs except allowed forms
- History of certain autoimmune diseases excluding stable hypothyroidism
- History of immunodeficiency or organ/bone marrow transplantation
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yiyi Yu, Doctor
CONTACT
M
Mengling Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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