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Starting soon Phase 2

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

NCT06310473 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-03
Last updated
2024-03-15

Condition(s) studied

Gastric CancerEsophagogastric Junction Cancer

Investigational drug(s) / intervention(s)

Cadonilimab →Oxaliplatin →Capecitabine →

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

Oxaliplatin: 130mg/m², iv drip for 2h, d1, q3w;

Capecitabine: 1000mg/m² po, Bid, d1-14, q3w ;

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hospital, Southern Medical University Guangzhou Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06310473 on ClinicalTrials.gov ↗ ← All trials in China