An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
- Conditions
- Gastric and Gastroesophageal Junction Carcinoma
- Interventions
- Registration Number
- NCT05251948
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population. Cohort 1 will enroll participants with inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology, who have not received prior systemic therapy for advanced or metastatic disease. Eligible participants will initially be randomly assigned to one of treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezo + CAPOX +Tira Tiragolumab 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. Atezo + CAPOX (capecitabine + oxaliplatin) Oxaliplatin 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. Atezo + CAPOX (capecitabine + oxaliplatin) Capecitabine 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. Atezo + CAPOX (capecitabine + oxaliplatin) Atezolizumab 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. Atezo + CAPOX +Tira Atezolizumab 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. Atezo + CAPOX +Tira Capecitabine 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. Atezo + CAPOX +Tira Oxaliplatin 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 3-5 years ORR is defined as the proportion of participants with a complete response or a partial response on two consecutive occasions \>= 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) At specific timepoints (up to approximately 3-5 years) OS at specific timepoints.
Progression-Free Survival (PFS) Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 3-5 years) PFS after randomization is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1.
Percentage of Participants with Adverse Events in Stage 1 Baseline through approximately end of study (approximately 3-5 years) Percentage of participants with adverse events in Stage 1.
Duration of Response (DOR) First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) (up to approximately 3-5 years) DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1.
Disease Control Rate Up to approximately 3-5 years Disease control rate is defined as the proportion of participants with stable disease for \>= 12 weeks or a complete or a partial response, as determined by the investigator according to RECIST v1.1.
Percentage of Participants with Adverse Events in Stage 2 Baseline through approximately end of study (approximately 3-5 years) Percentage of participants with adverse events in Stage 2.
Trial Locations
- Locations (12)
The General Hospital of People?s Liberation Army (301 Hospital)
🇨🇳Beijing City, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou City, China
the First Hospital of Jilin University
🇨🇳Changchun, China
First Affiliated Hospital of Gannan Medical University
🇨🇳Ganzhou, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, China
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
Affiliated Hopsital of Jining Medical University
🇨🇳Jining, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing City, China
Nan Tong Tumor Hospital
🇨🇳Nantong City, China
Shanxi Province Cancer Hospital
🇨🇳Taiyuan City, China
The First Affiliated Hospital of Xian Jiao Tong University
🇨🇳Xi'an City, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China