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

NCT ID: NCT06310473

Condition: Gastric Cancer
Esophagogastric Junction Cancer

Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Oxaliplatin

Conditions: Keywords:
bispecific antibody
Neoadjuvant
Immunotherapy and Chemotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cadonilimab
Description: 10mg/kg intravenous (IV) every 3 weeks ;
Arm group label: Cadonilimab Plus Chemotherapy

Other name: AK104

Intervention type: Drug
Intervention name: Oxaliplatin
Description: 130mg/m², iv drip for 2h, d1, q3w;
Arm group label: Cadonilimab Plus Chemotherapy

Intervention type: Drug
Intervention name: Capecitabine
Description: 1000mg/m² po, Bid, d1-14, q3w ;
Arm group label: Cadonilimab Plus Chemotherapy

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Nanfang Hospital, Southern Medical University

Address:
City: Guangzhou
Zip: 510-515
Country: China

Contact:
Last name: Guoxin Li, M.D., Ph.D.

Phone: +86-138-0277-1450
Email: gzliguoxin@163.com

Investigator:
Last name: Guoxin Li, M.D., Ph.D.
Email: Principal Investigator

Investigator:
Last name: Liying Zhao, M.D., Ph.D.
Email: Sub-Investigator

Start date: March 2024

Completion date: March 2028

Lead sponsor:
Agency: Nanfang Hospital, Southern Medical University
Agency class: Other

Source: Nanfang Hospital, Southern Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06310473

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