Clinical trial NCT05960955: Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Official title: Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance
timeFrame: Up to approximately 2 years
measure: Pathological complete response (pCR) rates
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Major pathological response(MPR) rates
timeFrame: Up to approximately 2 years
measure: Tumor regression grade(TRG)
timeFrame: Up to approximately 2 years
measure: R0 resection rate
timeFrame: Up to approximately 2 years
measure: Tumor descending stage rate
timeFrame: Up to approximately 2 years
measure: ORR
timeFrame: Up to approximately 2 years
measure: EFS
timeFrame: Up to approximately 2 years
measure: OS
timeFrame: Up to approximately 2 years
measure: PK
timeFrame: Up to approximately 2 years
measure: ADA
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Provincial Tumor Hospital
Study officials:
References: