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NCT04661150

A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction

Active, enrolled Phase 2 Results posted Last updated 16 April 2026
What this trial tests

Phase 2 trial testing Atezolizumab in Gastric Cancer in 42 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
12 March 2021
Primary endpoint
8 May 2023
30 July 2026

Quick facts

Lead sponsorHoffmann-La Roche
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment42
Start date12 March 2021
Primary completion8 May 2023
Estimated completion30 July 2026
Sites8 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 75, any sex, with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pathological Complete Regression (pCR) Rate Primary · Completion of neoadjuvant systemic therapy (up to approximately 16 months)

pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist..

GroupValue95% CI
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)38.118.1 – 61.6
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)14.33.0 – 36.3
Objective Response Rate (ORR) Secondary · Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months)

Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) during NAST, as determined by the investigator according to RECIST v1.1.

GroupValue95% CI
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)28.611.3 – 52.2
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)33.314.6 – 57.0
R0 Resection Rate Secondary · Surgery

R0 resection rate, defined as the proportion of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed and/or sampled regional lymph nodes based on evaluation by the local pathologist.

GroupValue95% CI
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)95.276.2 – 99.9
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)90.569.6 – 98.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Serious: 0/21 (0%)
Deaths: 2/21
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Serious: 0/21 (0%)
Deaths: 0/21
Other adverse events (77 terms — click to expand)

ReactionSystemArm A: Atezolizumab Plus T…Arm B: Trastuzumab With XE…
Platelet count decreasedInvestigations
NauseaGastrointestinal disorders
Weight decreasedInvestigations
AnaemiaBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
VomitingGastrointestinal disorders
Bilirubin conjugated increasedInvestigations
Blood bilirubin increasedInvestigations
Neutrophil count decreasedInvestigations
Aspartate aminotransferase increasedInvestigations
White blood cell count decreasedInvestigations
AstheniaGeneral disorders
HypokalaemiaMetabolism and nutrition disorders
Alanine aminotransferase increasedInvestigations
Blood bilirubin unconjugated increased 2Investigations
Weight increasedInvestigations
LeukocytosisBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
PyrexiaGeneral disorders
MalaiseGeneral disorders
HypocalcaemiaMetabolism and nutrition disorders
Wound complicationInjury, poisoning and procedural complications
Incision site painInjury, poisoning and procedural complications
ParaesthesiaNervous system disorders
Taste disorderNervous system disorders
Skin hyperpigmentationSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
Abdominal painGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
Gingival bleedingGastrointestinal disorders
IleusGastrointestinal disorders
Small intestinal obstructionGastrointestinal disorders
DyspepsiaGastrointestinal disorders
Amylase increasedInvestigations
Blood albumin decreasedInvestigations
Blood creatinine increasedInvestigations
Blood glucose increasedInvestigations
Blood pressure increasedInvestigations
Blood thyroid stimulating hormone increasedInvestigations
Blood urea increasedInvestigations

Data from ClinicalTrials.gov NCT04661150 adverse events section.

Sponsor's own description

This is a phase II, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of perioperative trastuzumab+XELOX with / without atezolizumab in participants eligible for surgery with locally advanced HER2-positive gastric cancer or adenocarcinoma of GEJ.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. HER2-targeted therapies in cancer: a systematic review.
    Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1
  2. PD-1 blockade synergizes with oxaliplatin-based, but not cisplatin-based, chemotherapy of gastric cancer.
    Liu P, Chen J, Zhao L, Hollebecque A, et al · · 2022 · cited 50× · PMID 35769948 · DOI 10.1080/2162402x.2022.2093518
  3. Human epidermal growth factor receptor 2 (HER2)-specific chimeric antigen receptor (CAR) for tumor immunotherapy; recent progress.
    Budi HS, Ahmad FN, Achmad H, Ansari MJ, et al · · 2022 · cited 44× · PMID 35093187 · DOI 10.1186/s13287-022-02719-0
  4. HER2-Positive Gastric Cancer: The Role of Immunotherapy and Novel Therapeutic Strategies.
    Pous A, Notario L, Hierro C, Layos L, et al · · 2023 · cited 32× · PMID 37511163 · DOI 10.3390/ijms241411403
  5. Targeted therapy and immunotherapy for gastric cancer: rational strategies, novel advancements, challenges, and future perspectives.
    Luo D, Liu Y, Lu Z, Huang L. · · 2025 · cited 31× · PMID 39923010 · DOI 10.1186/s10020-025-01075-y
  6. The current management and biomarkers of immunotherapy in advanced gastric cancer.
    Chang X, Ge X, Zhang Y, Xue X. · · 2022 · cited 26× · PMID 35623069 · DOI 10.1097/md.0000000000029304
  7. Optimizing the Choice for Adjuvant Chemotherapy in Gastric Cancer.
    Grassadonia A, De Luca A, Carletti E, Vici P, et al · · 2022 · cited 9× · PMID 36230592 · DOI 10.3390/cancers14194670
  8. Atezolizumab and Trastuzumab Plus Chemotherapy for ERBB2-Positive Locally Advanced Resectable Gastric Cancer: A Randomized Clinical Trial.
    Peng Z, Zhang X, Liang H, Zheng Z, et al · · 2025 · cited 8× · PMID 40244574 · DOI 10.1001/jamaoncol.2025.0522

Verify or expand the search:

Other trials of Atezolizumab

Trials testing the same drug.

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

Other Hoffmann-La Roche trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04661150.

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