An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
Gastric and Gastroesophageal Junction Carcinoma
About this trial
This is an interventional treatment trial for Gastric and Gastroesophageal Junction Carcinoma
Eligibility Criteria
Inclusion Criteria for Stage 1:
- ECOG Performance Status of 0 or 1
- Inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology
- No prior systemic treatment for advanced or metastatic disease
- Life expectancy >= 3 months, as determined by the investigator
- Human epidermal growth factor receptor 2 (HER2)-negative tumors
- Measurable disease according to RECIST v1.1
- Adequate hematologic and end-organ function
- Patients without hepatitis B virus (HBV) infection at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Negative HIV test at screening
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, as outlined for each specific treatment arm
- For men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Exclusion Criteria for Stage 1:
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Any contraindications to any of the study drugs of the chemotherapy regimen
- Eligible only for the control arm
- Patients with a signet ring cells dominant carcinoma
- Symptomatic, untreated, or actively progressing CNS metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of malignancy other than GC or GEJC within 2 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death
Exclusion Criteria for Tiragolumab-Containing Arm:
- Prior treatment with an anti-TIGIT agent
- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
Sites / Locations
- The General Hospital of People?s Liberation Army (301 Hospital)
- the First Hospital of Jilin University
- First Affiliated Hospital of Gannan Medical University
- The Sixth Affiliated Hospital of Sun Yat-sen University
- The First Affiliated Hospital, Zhejiang University
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
- Harbin Medical University Cancer Hospital
- The Second Affiliated Hospital of Anhui Medical University
- Affiliated Hopsital of Jining Medical University
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
- Nan Tong Tumor Hospital
- Shanxi Province Cancer Hospital
- The First Affiliated Hospital of Xian Jiao Tong University
- The First Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Active Comparator
Atezo + CAPOX (capecitabine + oxaliplatin)
Atezo + CAPOX +Tir
Atezo + CAPOX + AB011
CAPOX + AB011
Participants in the atezolizumab plus capecitabine plus oxaliplatin in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Participants in the atezolizumab plus capecitabine plus oxaliplatin plus tiragolumab arm in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Participants in the atezolizumab plus capecitabine plus oxaliplatin plus AB011 arm in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Participants in the capecitabine plus oxaliplatin plus AB011 arm in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator.