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

Launched by AKESO · Jul 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with resectable gastric or gastroesophageal junction adenocarcinoma, which is a type of stomach cancer. The researchers want to see if combining a medication called cadonilimab with chemotherapy (and possibly another drug called AK117) can be effective and safe for these patients before they undergo surgery. This trial is currently recruiting participants aged between 18 and 75 years who have a confirmed diagnosis of this type of cancer and meet certain health criteria.

To be eligible for this study, participants need to be in good overall health, meaning they can carry out daily activities with little to no assistance. They should not have any other serious health issues, such as significant heart problems or active infections. Those who join the trial can expect to receive treatment and regular monitoring to assess how well the medications are working and to check for any side effects. This research aims to improve treatment options for stomach cancer and may help future patients as well.

Gender

ALL

Eligibility criteria

• 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.