Gastric and Gastroesophageal Junction CarcinomaPhase 1/2NCT05251948
An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
A Phase 1/2 study testing Atezolizumab, Capecitabine and Oxaliplatin in people with Gastric and Gastroesophageal Junction Carcinoma, run by Hoffmann-La Roche at 11 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric and Gastroesophageal Junction Carcinoma
- What is being tested?
- Atezolizumab, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesChina
- Study dates
- 1 Mar 2022to 4 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
The General Hospital of People?s Liberation Army (301 Hospital)
Beijing, 100853
the First Hospital of Jilin University
Changchun, 130021
First Affiliated Hospital of Gannan Medical University
Ganzhou, 341000
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016
The Second Affiliated Hospital of Anhui Medical University
Hefei, 230601
Affiliated Hopsital of Jining Medical University
Jining, 272000
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008
Nan Tong Tumor Hospital
Nantong, 226361
Shanxi Province Cancer Hospital
Taiyuan, 030013
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061
About this study
Official title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma (MORPHEUS C-Gastric and Gastroesophageal Junction Carcinoma)
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.
- Being tested
- Atezolizumab, Capecitabine, Oxaliplatin, Tiragolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease.
CapecitabineDrug
Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles.
OxaliplatinDrug
Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles.
TiragolumabDrug
Tiragolumab is administered by IV infusion on Day 1 of each 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Atezo + CAPOX (capecitabine + oxaliplatin) | Active comparator | 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. Receives: Drug: Atezolizumab; Drug: Capecitabine; Drug: Oxaliplatin |
| Atezo + CAPOX +Tira | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Tiragolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions, ≥ 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off.
Measured: Up to 42.1 months
Secondary outcomes (6)
Progression-free Survival (PFS) After Randomization
PFS after randomization was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median PFS was estimated using the Kaplan-Meier (K-M) method.
Measured: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to 42.1 months)
Overall Survival (OS) After Randomization
OS was defined as the time from randomization to death from any cause, regardless of stage. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Median OS was estimated using the K-M method.
Measured: From randomization to death from any cause (up to 42.1 months)
OS Rates at Specified Timepoints
OS was defined as the time from randomization to death from any cause, regardless of stage. OS rate at 6 and 12 months was defined as the percentage of participants who did not experience death from any cause at these timepoints from randomization. OS rates at the specified timepoints were estimated using the K-M method. Percentages have been rounded off.
Measured: At Months 6 and 12
Duration of Response (DOR)
DOR was defined as time from the first occurrence of a documented objective response (OR), CR or PR to PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target/non-target lesions) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median DOR was estimated using the K-M method.
Measured: From first occurrence of CR or PR to PD or death from any cause, whichever occurred first (up to 42.1 months)
Disease Control Rate (DCR)
DCR was defined as percentage of participants with stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off.
Measured: Up to 42.1 months
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 42.1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Mar 2022
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Why it stopped: Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric and Gastroesophageal Junction CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251948
- Sponsor's protocol ID
- YO43408
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2022
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma (MORPHEUS C-Gastric and Gastroesophageal Junction Carcinoma)
- ClinicalTrials.gov ID
- NCT05251948
- Acronym / sponsor ID
- YO43408
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezo + CAPOX (capecitabine + oxaliplatin) | Active comparator | Drug: Atezolizumab, Drug: Capecitabine, Drug: OxaliplatinParticipants 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 | Experimental | Drug: Atezolizumab, Drug: Capecitabine, Drug: Oxaliplatin, Drug: TiragolumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqAtezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease. | Drug | Atezo + CAPOX (capecitabine + oxaliplatin), Atezo + CAPOX +Tira |
| CapecitabineCapecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles. | Drug | Atezo + CAPOX (capecitabine + oxaliplatin), Atezo + CAPOX +Tira |
| OxaliplatinOxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles. | Drug | Atezo + CAPOX (capecitabine + oxaliplatin), Atezo + CAPOX +Tira |
| TiragolumabTiragolumab is administered by IV infusion on Day 1 of each 21 day cycle. | Drug | Atezo + CAPOX +Tira |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 42.1 months
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions, ≥ 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off.
6 secondary outcomes
Progression-free Survival (PFS) After Randomization
Time frame: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to 42.1 months)
Overall Survival (OS) After Randomization
Time frame: From randomization to death from any cause (up to 42.1 months)
OS Rates at Specified Timepoints
Time frame: At Months 6 and 12
Duration of Response (DOR)
Time frame: From first occurrence of CR or PR to PD or death from any cause, whichever occurred first (up to 42.1 months)
Disease Control Rate (DCR)
Time frame: Up to 42.1 months
Number of Participants With Adverse Events (AEs)
Time frame: Up to 42.1 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab, Capecitabine and Oxaliplatin in people with Gastric and Gastroesophageal Junction Carcinoma, run by Hoffmann-La Roche at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 42.1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.