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

Locally Advanced Unresectable Gastric Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974059
• Other study ID #: AK104-IIT-C-N1-0036
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Xuewei Ding, MD
• Phone: 18622220158
• Email: xding[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female, 18 years = age = 75 years;

2. ECOG score 0-1;

3. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction.

4. 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).

5. 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;

6. Physical condition and organ function allow for larger abdominal surgery;

7. 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

1. Complication of upper gastrointestinal tract obstruction/hemorrhage or digestive dysfunction or malabsorption syndrome;

2. Concomitant severe uncontrolled concurrent infection or other serious uncontrolled concomitant disease, moderate or severe renal injury;

3. Prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy;

4. Other malignancies (except basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;

5. Uncontrolled pleural effusion, pericardial effusion or ascites;

6. Serious cardiovascular disease such as symptomatic coronary heart disease, congestive heart failure =Grade II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment;

7. Allergic reaction to the drugs used in this study;

8. Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment;

9. Patients receiving study medication within 4 weeks prior to enrollment (participating in other clinical trials);

10. Active autoimmune diseases;

11. Medical history of primary immunodeficiency;

12. 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;

13. Receiving an attenuated live vaccine within 4 weeks prior to the first dose of study treatment or scheduled for the duration of the study;

14. Known active tuberculosis;

15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;

16. HIV antibody positive, active hepatitis B or hepatitis C (HBV, HCV);

17. Pregnant or lactating women;

Related Conditions & MeSH terms

• Adenocarcinoma
• Locally Advanced Unresectable Gastric Adenocarcinoma

Intervention

Drug:
• Oxaliplatin
Preoperative treatment:130mg/m2,iv, 2h,d1,Q3W; Postoperative treatment:130mg/m2,iv, 2h,d1,Q3W;
• Capecitabine
Preoperative treatment:1000 mg /m2, PO,bid d1-14,Q3W; Postoperative treatment:1000 mg /m2, PO,bid. d1-14,Q3W;
• Cadonilimab
Cadonilimab 10 mg/kg, d1, Q3W

Locations

Country	Name	City	State
China	Xuewei Ding	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 years
Secondary	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	up to 3 years
Secondary	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	up to 1 years
Secondary	Objective response rate(ORR)	Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR	up to 3 years
Secondary	Disease Control Rate (DCR)	Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR#PR or SD	up to 3 years
Secondary	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	up to 3 years