Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Akeso

Status and phase: Enrolling; Phase 2

Conditions: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: 5-Fluorouracil; Drug: Tegafur-gimeracil-oteracil potassium; Drug: Docetaxel; Drug: Cadonilimab; Drug: Oxaliplatin; Drug: AK117

Study type: Interventional

Funder types: Industry

Identifiers

NCT05960955

AK104-219

Details and patient eligibility

About

This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be able and willing to provide written informed consent.
• 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

• Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 4 patient groups

Part 1 cohort 1

Experimental group

Description:

Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.

Treatment:

Drug: Cadonilimab

Drug: Oxaliplatin

Drug: Tegafur-gimeracil-oteracil potassium

Part 1 cohort 2

Experimental group

Description:

Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.

Treatment:

Drug: Cadonilimab

Drug: Oxaliplatin

Drug: AK117

Drug: Tegafur-gimeracil-oteracil potassium

Part 2 cohort 1

Experimental group

Description:

Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.

Treatment:

Drug: Cadonilimab

Drug: Oxaliplatin

Drug: 5-Fluorouracil

Drug: Docetaxel

Part 2 cohort 2

Experimental group

Description:

Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.

Treatment:

Drug: Cadonilimab

Drug: Oxaliplatin

Drug: AK117

Drug: 5-Fluorouracil

Drug: Docetaxel