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Not yet recruiting NCT06310473

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

Phase II Interventional Gastric Cancer Esophagogastric Junction Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cadonilimab, Oxaliplatin, Capecitabine.
Who it may be relevant to
Registry conditions: Gastric Cancer, Esophagogastric Junction Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Neoadjuvant Cadonilimab and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer : a Prospective, Open-label, Single-Arm Phase II Study

Overview

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

  • Drug Cadonilimab
    10mg/kg intravenous (IV) every 3 weeks ;
  • Drug Oxaliplatin
    130mg/m², iv drip for 2h, d1, q3w;
  • Drug Capecitabine
    1000mg/m² po, Bid, d1-14, q3w ;

Primary outcome measures

  • Pathologic complete remission rate (pCR) [Time frame: up to 1 years]
Secondary outcome measures (6)
  • Major pathologic response，MPR [Time frame: up to 1 years]
  • R0 resection rate [Time frame: up to 1 years]
  • Objective Response Rate (ORR) [Time frame: up to 3 years]
  • Disease Control Rate (DCR) [Time frame: up to 3 years]
  • 3-year disease-free survival rate of 3year (DFS) [Time frame: up to 3 years]
  • Overall Survival (OS) [Time frame: up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT06310473 · NFEC-2023-582

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗