NCT03448835

Brief Summary

In this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment. The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
3mo left

Started Mar 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2018Oct 2026

First Submitted

Initial submission to the registry

November 22, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

8.7 years

First QC Date

November 22, 2017

Last Update Submit

June 4, 2025

Conditions

Stomach CancerGastro Esophageal Junction Cancer

Keywords

short term immunotherapysurgical resectionatezolizumabcapecitabineoxaliplatindocetaxel

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events following treatment (safety)

    Adverse events will be assessed (according to CTC-AE v4.0) during treatment

    until 100 days after last patient last study drug treatment

Secondary Outcomes (1)

  • pathological tumor regression grade

    Within 6 months after last patient inclusion

Study Arms (1)

atezolizumab and chemotherapy

EXPERIMENTAL

1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel

Drug: AtezolizumabDrug: CapecitabineDrug: OxaliplatinDrug: Docetaxel

Interventions

AtezolizumabDRUG

atezolizumab 1200 mg 5 cycles

Also known as: MPDL3280A
atezolizumab and chemotherapy
CapecitabineDRUG

capecitabine 850 mg /m2 4 cycles

Also known as: L01BC06
atezolizumab and chemotherapy
OxaliplatinDRUG

oxaliplatin 100 mg/m2 4 cycles

Also known as: L01XA03
atezolizumab and chemotherapy
DocetaxelDRUG

docetaxel 50 mg/m2 4 cycles

Also known as: L01CD02
atezolizumab and chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent
  • patients age 18 and older
  • primary resectable, histologically confirmed gastric or GEJ adenocarcinoma

You may not qualify if:

  • no signs of distant metastases
  • no active or history of autoimmune disease or immune deficiency
  • no significant cardiovascular disease
  • no major surgical procedure within 4 weeks prior to initiation of study treatment
  • no current treatment with anti-viral therapy or HBV
  • no pregnancy or breastfeeding
  • no history of malignancy within 3 years prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marieke van de Belt

Amsterdam, 1066CX, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Netherlands

Location

Related Publications (2)

  • Verschoor YL, van de Haar J, van den Berg JG, van Sandick JW, Kodach LL, van Dieren JM, Balduzzi S, Grootscholten C, IJsselsteijn ME, Veenhof AAFA, Hartemink KJ, Vollebergh MA, Jurdi A, Sharma S, Spickard E, Owers EC, Bartels-Rutten A, den Hartog P, de Miranda NFCC, van Leerdam ME, Haanen JBAG, Schumacher TN, Voest EE, Chalabi M. Neoadjuvant atezolizumab plus chemotherapy in gastric and gastroesophageal junction adenocarcinoma: the phase 2 PANDA trial. Nat Med. 2024 Feb;30(2):519-530. doi: 10.1038/s41591-023-02758-x. Epub 2024 Jan 8.

    PMID: 38191613DERIVED

  • 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.

    PMID: 35623069DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

atezolizumabCapecitabineOxaliplatinDocetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Myriam Chalabi, MD

    Antoni van Leeuwenhoek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single group, open label
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

February 28, 2018

Study Start

March 7, 2018

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)