An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma

NCT ID: NCT05251948

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-09-04

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.

Conditions

Gastric and Gastroesophageal Junction Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atezo + CAPOX (capecitabine + 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.

Group Type: ACTIVE_COMPARATOR

Atezolizumab

Intervention Type: DRUG

Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.

Capecitabine

Intervention Type: DRUG

Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.

Atezo + CAPOX +Tira

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.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.

Capecitabine

Intervention Type: DRUG

Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.

Tiragolumab

Intervention Type: DRUG

Tiragolumab is administered by IV infusion on Day 1 of each 21 day cycle.

Interventions

Atezolizumab

Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.

Intervention Type: DRUG

Capecitabine

Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.

Intervention Type: DRUG

Tiragolumab

Tiragolumab is administered by IV infusion on Day 1 of each 21 day cycle.

Intervention Type: DRUG

Other Intervention Names

Tecentriq

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Prior treatment with an anti-TIGIT agent
• Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

The General Hospital of People?s Liberation Army (301 Hospital)

Beijing, , China

the First Hospital of Jilin University

Changchun, , China

First Affiliated Hospital of Gannan Medical University

Ganzhou, , China

The First Affiliated Hospital, Zhejiang University

Hangzhou, , 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, , China

Nan Tong Tumor Hospital

Nantong, , China

Shanxi Province Cancer Hospital

Taiyuan, , China

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, , China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Countries

China

Other Identifiers

YO43408

Identifier Type: -

Identifier Source: org_study_id