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Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer

Primary Purpose

Locally Advanced Unresectable Gastric Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Capecitabine
Cadonilimab
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Unresectable Gastric Adenocarcinoma focused on measuring Resectable locally advanced adenocarcinoma of the gastro-esophageal junction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 1)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; Concomitant severe uncontrolled concurrent infection or other serious uncontrolled concomitant disease, moderate or severe renal injury; Prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy; Other malignancies (except basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years; Uncontrolled pleural effusion, pericardial effusion or ascites; Serious cardiovascular disease such as symptomatic coronary heart disease, congestive heart failure ≥Grade II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment; Allergic reaction to the drugs used in this study; Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment; Patients receiving study medication within 4 weeks prior to enrollment (participating in other clinical trials); Active autoimmune diseases; Medical history of primary immunodeficiency; Immunosuppressive medications were used within 4 weeks prior to the first dose of study treatment, excluding nasal spray, inhaled or other local corticosteroids or physiological doses of systemic corticosteroids (i.e. not more than 10 mg/day prednisone or equivalent dose of other corticosteroids), or the use of hormones to prevent contrast agent allergy; Receiving an attenuated live vaccine within 4 weeks prior to the first dose of study treatment or scheduled for the duration of the study; Known active tuberculosis; Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV); Pregnant or lactating women;

Sites / Locations

  • Xuewei Ding

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cadonilimab

Arm Description

10 mg/kg, d1, Q3W;

Outcomes

Primary Outcome Measures

Pathologic complete remission rate (PCR)
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 Outcome Measures

3-year disease-free survival rate of 3year (DFS)
3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment
Major pathological response rate (MPR)
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist
Objective response rate(ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD
Adverse Events(AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

Full Information

First Posted
July 24, 2023
Last Updated
August 2, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05974059
Brief Title
Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Unresectable Gastric Adenocarcinoma
Keywords
Resectable locally advanced adenocarcinoma of the gastro-esophageal junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cadonilimab
Arm Type
Experimental
Arm Description
10 mg/kg, d1, Q3W;
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Preoperative treatment:130mg/m2,iv, 2h,d1,Q3W; Postoperative treatment:130mg/m2,iv, 2h,d1,Q3W;
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Preoperative treatment:1000 mg /m2, PO,bid d1-14,Q3W; Postoperative treatment:1000 mg /m2, PO,bid. d1-14,Q3W;
Intervention Type
Drug
Intervention Name(s)
Cadonilimab
Intervention Description
Cadonilimab 10 mg/kg, d1, Q3W
Primary Outcome Measure Information:
Title
Pathologic complete remission rate (PCR)
Description
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.
Time Frame
up to 1 years
Secondary Outcome Measure Information:
Title
3-year disease-free survival rate of 3year (DFS)
Description
3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment
Time Frame
up to 3 years
Title
Major pathological response rate (MPR)
Description
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist
Time Frame
up to 1 years
Title
Objective response rate(ORR)
Description
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Time Frame
up to 3 years
Title
Disease Control Rate (DCR)
Description
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD
Time Frame
up to 3 years
Title
Adverse Events(AEs)
Description
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 1)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; Concomitant severe uncontrolled concurrent infection or other serious uncontrolled concomitant disease, moderate or severe renal injury; Prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy; Other malignancies (except basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years; Uncontrolled pleural effusion, pericardial effusion or ascites; Serious cardiovascular disease such as symptomatic coronary heart disease, congestive heart failure ≥Grade II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment; Allergic reaction to the drugs used in this study; Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment; Patients receiving study medication within 4 weeks prior to enrollment (participating in other clinical trials); Active autoimmune diseases; Medical history of primary immunodeficiency; Immunosuppressive medications were used within 4 weeks prior to the first dose of study treatment, excluding nasal spray, inhaled or other local corticosteroids or physiological doses of systemic corticosteroids (i.e. not more than 10 mg/day prednisone or equivalent dose of other corticosteroids), or the use of hormones to prevent contrast agent allergy; Receiving an attenuated live vaccine within 4 weeks prior to the first dose of study treatment or scheduled for the duration of the study; Known active tuberculosis; Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV); Pregnant or lactating women;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuewei Ding, MD
Phone
18622220158
Email
xding@tmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuewei Ding, MD
Organizational Affiliation
Tianjin Cancer Hospital Airport Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xuewei Ding
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300308
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuewei Ding, MD
Phone
18622220158
Email
xding@tmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer

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