Esophagogastric Junction Cancer, Gastric Cancer
Conditions
Keywords
bispecific antibody, Neoadjuvant, Immunotherapy and Chemotherapy
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.
Interventions
DRUGCadonilimab
10mg/kg intravenous (IV) every 3 weeks ;
DRUGOxaliplatin
130mg/m², iv drip for 2h, d1, q3w;
DRUGCapecitabine
1000mg/m² po, Bid, d1-14, q3w ;
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | up to 1 years | Rate of microscopically margin-negative resection |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D., Ph.D
Outcome results
None listed