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

March 7, 2024 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510-515
        • Nanfang Hospital, Southern Medical University
        • Sub-Investigator:
          • Liying Zhao, M.D., Ph.D.
        • Contact:
        • Principal Investigator:
          • Guoxin Li, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cadonilimab Plus Chemotherapy

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
10mg/kg intravenous (IV) every 3 weeks ;
Other Names:
  • AK104
Drug: Oxaliplatin
130mg/m², iv drip for 2h, d1, q3w;
Drug: Capecitabine
1000mg/m² po, Bid, d1-14, q3w ;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete remission rate (pCR)
Time Frame: 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.
up to 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival rate of 3year (DFS)
Time Frame: 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
up to 3 years
Major pathologic response，MPR
Time Frame: 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
up to 1 years
R0 resection rate
Time Frame: up to 1 years
Rate of microscopically margin-negative resection
up to 1 years
Objective Response Rate (ORR)
Time Frame: 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.
up to 3 years
Disease Control Rate (DCR)
Time Frame: 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.
up to 3 years
Overall Survival (OS)
Time Frame: 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.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Guoxin Li, M.D., Ph.D, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2023-582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Cadonilimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe