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

Phase 2

Not yet recruiting

• Conditions: Gastric Cancer; Esophagogastric Junction Cancer
• Interventions: Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Capecitabine

• Registration Number: NCT06310473
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-20
• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadonilimab Plus Chemotherapy	Cadonilimab	Neoadjuvant Immunotherapy and Chemotherapy：Cadonilimab+Oxaliplatin+Capecitabine, every 3 weeks for 3 cycles; Adjuvant chemotherapy： Oxaliplatin+Capecitabine, every 3 weeks for 3-5 cycles;
Cadonilimab Plus Chemotherapy	Oxaliplatin	Neoadjuvant Immunotherapy and Chemotherapy：Cadonilimab+Oxaliplatin+Capecitabine, every 3 weeks for 3 cycles; Adjuvant chemotherapy： Oxaliplatin+Capecitabine, every 3 weeks for 3-5 cycles;
Cadonilimab Plus Chemotherapy	Capecitabine	Neoadjuvant Immunotherapy and Chemotherapy：Cadonilimab+Oxaliplatin+Capecitabine, every 3 weeks for 3 cycles; Adjuvant chemotherapy： Oxaliplatin+Capecitabine, every 3 weeks for 3-5 cycles;

Primary Outcome Measures

Name	Time	Method
Pathologic complete remission rate (pCR)	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 Outcome Measures

Name	Time	Method
3-year disease-free survival rate of 3year (DFS)	up to 3 years	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
Objective Response Rate (ORR)	up to 3 years	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.
Disease Control Rate (DCR)	up to 3 years	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.
Major pathologic response，MPR	up to 1 years	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
R0 resection rate	up to 1 years	Rate of microscopically margin-negative resection
Overall Survival (OS)	up to 3 years	defined as the time between the date of first dose of study drug and the date of death due to any cause.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China