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Gastric CancerPhase 2NCT04661150

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

A Phase 2 study testing Atezolizumab, Trastuzumab and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Hoffmann-La Roche at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Atezolizumab, Trastuzumab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
8 sitesChina
Study dates
12 Mar 2021to 27 Jul 2026
Phase
Phase 2

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed gastric cancer or adenocarcinoma of GEJ
  • HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed by local review based on pretreatment endoscopic biopsies.
  • Clinical stage at presentation: cT3/T4a/T4b, or N+, M0 as determined by AJCC staging system, 8th edition
  • Availability of pretreatment tumor specimen for biomarker analysis by central lab
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy >= 12 weeks
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  • Adequate hematologic and end-organ function
  • For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception during the treatment period and to continue its use for at least i) 5 months after the last dose of atezolizumab, ii) 7 months after the last dose of trastuzumab, or iii) 6 months after the last dose of capecitabine or oxaliplatin, whichever is longer.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Who cannot join

  • Stage IV (metastatic) or unresectable gastric/GEJ cancer determined by investigators
  • Prior systemic therapy for treatment of gastric cancer
  • History of malignancy other than GC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Cardiopulmonary dysfunction
  • Dyspnea at rest
  • Active or history of autoimmune disease or immune deficiency with the following exceptions: (a) Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid-replacement hormone are eligible for the study. (b) Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. (c) Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided allof following conditions are met: (i) Rash must cover < 10% of body surface area (ii) Disease is well controlled at baseline and requires only low-potency topical corticosteroids (iii) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
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  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Active tuberculosis
  • Patients with active hepatitis B
  • Patients with active hepatitis C

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Liaoning Provincial Cancer Hospital

    Shengyang, 110042

  • First Hospital of China Medical University

    Shenyang, 110001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing, 300060

Other trials in China

About this study

Official title: A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) and Trastuzumab in Combination With Capecitabine and Oxaliplatin (Xelox) in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction (GEJ)

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.

Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 3 cycles prior to surgery and 5 cycles after surgery.

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab will be administered as an 8 mg/kg IV loading dose and then 6 mg/kg IV on Day 1 of a 21-day cycle for 3 cycles before surgery, and administration will continue after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg.

  • CapecitabineDrug

    Capecitabine 1000 mg/m^2 will be administered twice orally on Days 1-14, repeated every 3 weeks.

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m^2 will be administered by IV on Day 1 of a 21-day cycle.

Study groups in NCT04661150
Study groupRoleWhat they receive
Arm A: Atezolizumab plus Trastuzumab with XELOX (Capecitabine + Oxaliplatin)ExperimentalParticipants will receive atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, patrticipants will receive 5 further cycles of this regimen.
Receives: Drug: Atezolizumab; Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin
Arm B: Trastuzumab with XELOX (Capecitabine + Oxaliplatin)Active comparatorParticipants will receive trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants will receive 5 further cycles of this regimen.
Receives: Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Regression (pCR) Rate

    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..

    Measured: Completion of neoadjuvant systemic therapy (up to approximately 16 months)

Secondary outcomes (7)

  1. Event-free Survival (EFS)

    Event-free survival (EFS), defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.

    Measured: Randomization to the first documented disease recurrence, unequivocal tumor progression or death from any cause, whichever occurs first (up to approximately 52 months)

  2. Disease-Free Survival (DFS)

    Disease-free survival (DFS), defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first.

    Measured: Surgery to first documented disease recurrence or death from any cause, whichever occurs first (up to approximately 52 months)

  3. Overall Survival (OS)

    Overall survival (OS), defined as the time from randomization to death from any cause in all patients.

    Measured: Randomiation to death from any cause (up to approximately 52 months)

  4. Major Pathologic Response (MPR)

    Major pathologic response (MPR), defined as < 10% residual tumor per tumor bed based on evaluation of the resected primary esophagogastric specimen by a local pathologist.

    Measured: Randomization up to approximately 16 months

  5. Objective Response Rate (ORR)

    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.

    Measured: Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months)

  6. R0 Resection Rate

    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.

    Measured: Surgery

  7. Percentage of Participants With Adverse Events

    Measured: Baseline through the end of study (approximately 52 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start12 Mar 2021
  3. Primary completion8 May 2023
  4. Study completion27 Jul 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04661150
Sponsor's protocol ID
ML42058
Status last verified
Aug 2026
First submitted
3 Dec 2020
Last updated
10 Sep 2026
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

Publications

  • Peng Z, Zhang X, Liang H, Zheng Z, Wang Z, Liu H, Hu J, Sun Y, Zhang Y, Yan H, Tong L, Xu J, Ji J, Shen L. Atezolizumab and Trastuzumab Plus Chemotherapy for ERBB2-Positive Locally Advanced Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025 Jun 1;11(6):619-624. doi: 10.1001/jamaoncol.2025.0522.

    PubMed 40244574

  • Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

    PubMed 35623069

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