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

NCT06310473 | Not Yet Recruiting Phase 2

• 1 other identifier: NFEC-2023-582
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Esophagogastric Junction Cancer

Keywords

bispecific antibody; Neoadjuvant; Immunotherapy and Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Major pathologic response，MPR

  up to 1 years

• R0 resection rate

  up to 1 years

• Objective Response Rate (ORR)

  up to 3 years

• Disease Control Rate (DCR)

  up to 3 years

• 3-year disease-free survival rate of 3year (DFS)

  up to 3 years

Study Arms (1)

Cadonilimab Plus Chemotherapy

EXPERIMENTAL

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

Drug: Cadonilimab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Cadonilimab DRUG

10mg/kg intravenous (IV) every 3 weeks ;

Also known as: AK104

Cadonilimab Plus Chemotherapy

Oxaliplatin DRUG

130mg/m², iv drip for 2h, d1, q3w;

Cadonilimab Plus Chemotherapy

Capecitabine DRUG

1000mg/m² po, Bid, d1-14, q3w ;

Cadonilimab Plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.
• Imaging (CT/MRI) and diagnostic laparoscopy confirmed at the stage of cT3-4aN1-3M0(AJCC 8th) .
• Physical condition and organ function allow for for larger abdominal surgery.
• Adequate haematological, renal and liver function.

You may not qualify if:

• Patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.
• Confirmed at stage IV (AJCC 8th) or unresectable by investigator.
• Prior chemotherapy, radiotherapy, surgery immunotherapy or molecular targeted therapy for gastric cancer.
• Patients are allergic to study medication and its ingredients.
• Known active autoimmune diseases.
• Presence of other uncontrolled serious medical conditions.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510-515, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Guoxin Li, M.D., Ph.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxin Li, M.D., Ph.D

CONTACT

+86 13802771450; gzliguoxin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)