Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial

Gastric Cancer Clinical Trial

Official title:

Efficacy and Safety of Neoadjuvant Cadonilimab and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer : a Prospective, Open-label, Single-Arm Phase II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310473
• Other study ID #: NFEC-2023-582
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: March 2028

Study information

• Verified date: March 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Guoxin Li, M.D., Ph.D
• Phone: +86 13802771450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early , and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer.

Description:

Locally advanced esophagogastric junction and gastric cancer could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can downstage T and N stage, treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory.Cadonilimab (AK104), a novel bispecific antibody simultaneously targeting PD-1 and CTLA-4, was designed to boost anti-tumor activity with a favorable safety profile.This study was a single arm, open-label clinical study to evaluate the efficacy and safety of combination with Cadonilimab and Chemotherapy for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2028
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.

2. Imaging (CT/MRI) and diagnostic laparoscopy confirmed at the stage of cT3-4aN1-3M0(AJCC 8th) .

3. Physical condition and organ function allow for for larger abdominal surgery.

4. Adequate haematological, renal and liver function.

Key Exclusion Criteria:

1. Patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.

2. Confirmed at stage IV (AJCC 8th) or unresectable by investigator.

3. Prior chemotherapy, radiotherapy, surgery immunotherapy or molecular targeted therapy for gastric cancer.

4. Patients are allergic to study medication and its ingredients.

5. Known active autoimmune diseases.

6. Presence of other uncontrolled serious medical conditions.

Related Conditions & MeSH terms

• Esophagogastric Junction Cancer
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Cadonilimab
10mg/kg intravenous (IV) every 3 weeks ;
• Oxaliplatin
130mg/m², iv drip for 2h, d1, q3w;
• Capecitabine
1000mg/m² po, Bid, d1-14, q3w ;

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

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	Major pathologic response,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	R0 resection rate	Rate of microscopically margin-negative resection	up to 1 years
Secondary	Objective Response Rate (ORR)	defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.	up to 3 years
Secondary	Disease Control Rate (DCR)	defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.	up to 3 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	Overall Survival (OS)	defined as the time between the date of first dose of study drug and the date of death due to any cause.	up to 3 years