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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer Esophagogastric Junction Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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;

Group Type EXPERIMENTAL

Cadonilimab

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

130mg/m², iv drip for 2h, d1, q3w;

Capecitabine

Intervention Type DRUG

1000mg/m² po, Bid, d1-14, q3w ;

Interventions

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Cadonilimab

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

Intervention Type DRUG

Oxaliplatin

130mg/m², iv drip for 2h, d1, q3w;

Intervention Type DRUG

Capecitabine

1000mg/m² po, Bid, d1-14, q3w ;

Intervention Type DRUG

Other Intervention Names

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AK104

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No