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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