Stomach CancerPhase 2PANDANCT03448835
Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)
A Phase 2 study testing Atezolizumab, Capecitabine and Oxaliplatin in people with Stomach Cancer and Gastro Esophageal Junction Cancer, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer, Gastro Esophageal Junction Cancer
- What is being tested?
- Atezolizumab, Capecitabine and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- 7 Mar 2018to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- signed informed consent
- patients age 18 and older
- primary resectable, histologically confirmed gastric or GEJ adenocarcinoma
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Marieke van de Belt
Amsterdam, 1066CX
Catharina ziekenhuis
Eindhoven
About this study
Official title: Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial
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.
Read the detailed description
In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction.
All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.
- Conditions
- Stomach Cancer, Gastro Esophageal Junction Cancer
- Being tested
- Atezolizumab, Capecitabine, Oxaliplatin, Docetaxel
- Keywords
- short term immunotherapy, surgical resection, atezolizumab, capecitabine, oxaliplatin, docetaxel
- 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 MPDL3280A
atezolizumab 1200 mg 5 cycles
CapecitabineDrug
Also called L01BC06
capecitabine 850 mg /m2 4 cycles
OxaliplatinDrug
Also called L01XA03
oxaliplatin 100 mg/m2 4 cycles
DocetaxelDrug
Also called L01CD02
docetaxel 50 mg/m2 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| atezolizumab and chemotherapy | Experimental | 1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel Receives: Drug: Atezolizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events following treatment (safety)
Adverse events will be assessed (according to CTC-AE v4.0) during treatment
Measured: until 100 days after last patient last study drug treatment
Secondary outcomes (1)
pathological tumor regression grade
determined using the Mandard tumor regression grading system
Measured: Within 6 months after last patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start7 Mar 2018
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, open label
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Myriam Chalabi, MD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448835
- Sponsor's protocol ID
- N17PND
- Acronym
- PANDA
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2017
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38191613Chang 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial
- ClinicalTrials.gov ID
- NCT03448835
- Acronym / sponsor ID
- PANDA / N17PND
- Conditions
- Stomach Cancer, Gastro Esophageal Junction Cancer
- Keywords
- short term immunotherapy, surgical resection, atezolizumab, capecitabine, oxaliplatin, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction.
All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, open label
| Arm | Type | Receives |
|---|---|---|
| atezolizumab and chemotherapy | Experimental | Drug: Atezolizumab, Drug: Capecitabine, Drug: Oxaliplatin, Drug: Docetaxel1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- patients age 18 and older
- primary resectable, histologically confirmed gastric or GEJ adenocarcinoma
Key exclusion criteria (7 listed)
- 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
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: MPDL3280Aatezolizumab 1200 mg 5 cycles | Drug | atezolizumab and chemotherapy |
| CapecitabineAlso: L01BC06capecitabine 850 mg /m2 4 cycles | Drug | atezolizumab and chemotherapy |
| OxaliplatinAlso: L01XA03oxaliplatin 100 mg/m2 4 cycles | Drug | atezolizumab and chemotherapy |
| DocetaxelAlso: L01CD02docetaxel 50 mg/m2 4 cycles | Drug | atezolizumab and chemotherapy |
Primary outcome
Incidence of adverse events following treatment (safety)
Time frame: until 100 days after last patient last study drug treatment
Adverse events will be assessed (according to CTC-AE v4.0) during treatment
1 secondary outcome
pathological tumor regression grade
Time frame: Within 6 months after last patient inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 38191613Verschoor 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.
- Derived from this study: PubMed 35623069Chang 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.
- Individual participant dataSharing planned: No
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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.
Myriam Chalabi, MD principal investigator
Antoni van Leeuwenhoek
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Capecitabine and Oxaliplatin in people with Stomach Cancer and Gastro Esophageal Junction Cancer, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of adverse events following treatment (safety) (time frame: until 100 days after last patient last study drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448835, which also lists 2 linked publications.
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 30 Sep 2026.