NCT05974059
Not yet recruiting
Phase 2
Single-arm, Open-label, Single-center Phase II Clinical Study of Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country20 target enrollmentStarted: August 1, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pathologic complete remission rate (PCR)
Overview
Brief Summary
The efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
Detailed Description
This study was a single arm, open-label, single-center clinical study to evaluate the efficacy and safety of combination with Cadonilimab and CapeOX Regimen for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, 18 years ≤ age ≤ 75 years;
- •ECOG score 0-1;
- •Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction.
- •c stageII, III(T1-4a/N+ M0, T3-4a/N-M0, AJCC 8th edition of gastric cancer cTNM stage) were performed according to enhanced CT/MRI examination (combined with ultrasonic gastroscopy and diagnostic laparoscopy if necessary).
- •The study site and the operator can complete radical dissection of D2 lymph nodes (the number of examined lymph nodes must be at least 15 to ensure the operation quality), and R0 resection;
- •Physical condition and organ function allow for larger abdominal surgery;
- •It has adequate organ and bone marrow functions and is defined as follows:
- •Blood routine test: absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count(PLT)≥100×109/L; Hemoglobin (HGB)≥9.0 g/dL; 2)Liver function: Total serum bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) is required for patients without liver metastasis. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5\*ULN; 3)Renal function: creatinine clearance rate (Ccr)≥50 mL/min (calculated by Cockcroft/Gault formula); a Female: Ccr= (140-years) x Body Weight (kg) x 0.85 72 x serum creatinine (mg/dL) b Males: Ccr= (140-years) x Weight (kg) x 1.00 72 x serum creatinine (mg/dL) 4) Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT is within the intended range of the anticoagulant; 8 Left ventricular ejection fraction (LVEF)≥50% confirmed by echocardiography; 9 Agree and be able to comply with the protocol during the study; 10 Provide written informed consent prior to entering study screening and the patient is aware that she can withdraw from the study at any time during the study without loss; 11 Consent to provide blood and histological specimens
- •Exclusion Criteria
- •Complication of upper gastrointestinal tract obstruction/hemorrhage or digestive dysfunction or malabsorption syndrome;
Exclusion Criteria
- Not provided
Arms & Interventions
Cadonilimab
Experimental
10 mg/kg, d1, Q3W;
Intervention: Oxaliplatin (Drug)
Cadonilimab
Experimental
10 mg/kg, d1, Q3W;
Intervention: Capecitabine (Drug)
Cadonilimab
Experimental
10 mg/kg, d1, Q3W;
Intervention: Cadonilimab (Drug)
Outcomes
Primary Outcomes
Pathologic complete remission rate (PCR)
Time Frame: up to 1 years
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Secondary Outcomes
- Disease Control Rate (DCR)(up to 3 years)
- Adverse Events（AEs）(up to 3 years)
- 3-year disease-free survival rate of 3year (DFS)(up to 3 years)
- Major pathological response rate (MPR)(up to 1 years)
- Objective response rate(ORR)(up to 3 years)
Investigators
Study Sites (1)
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