Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT05960955
Last Updated: 2023-11-18
Study Results
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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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2023-11-13
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 cohort 1
Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.
Cadonilimab
IV infusion,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Tegafur-gimeracil-oteracil potassium
Oral,Specified dose on specified days
Part 1 cohort 2
Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
Cadonilimab
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Tegafur-gimeracil-oteracil potassium
Oral,Specified dose on specified days
Part 2 cohort 1
Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
Cadonilimab
IV infusion,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
5-Fluorouracil
IV infusion,Specified dose on specified days
Part 2 cohort 2
Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.
Cadonilimab
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
5-Fluorouracil
IV infusion,Specified dose on specified days
Interventions
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Cadonilimab
IV infusion,Specified dose on specified days
AK117
IV infusion,Specified dose on specified days
Oxaliplatin
IV infusion,Specified dose on specified days
Tegafur-gimeracil-oteracil potassium
Oral,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
5-Fluorouracil
IV infusion,Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 18 to 75 years old.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ).
* Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer \[AJCC\])
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Has adequate organ function.
Exclusion Criteria
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has undergone major surgery within 30 days of Study Day 1.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Tianjin Provincial Tumor Hospital
Tianjin, , China
Countries
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Central Contacts
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Han Liang, MD
Role: CONTACT
Facility Contacts
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Han Liang, MD
Role: primary
Other Identifiers
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AK104-219
Identifier Type: -
Identifier Source: org_study_id
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