search
Back to results

Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA) (PANDA)

Primary Purpose

Stomach Cancer, Gastro Esophageal Junction Cancer

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Atezolizumab
Capecitabine
Oxaliplatin
Docetaxel
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring short term immunotherapy, surgical resection, atezolizumab, capecitabine, oxaliplatin, docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Marieke van de BeltRecruiting
  • Catharina ziekenhuisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

atezolizumab and chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of adverse events following treatment (safety)
Adverse events will be assessed (according to CTC-AE v4.0) during treatment

Secondary Outcome Measures

pathological tumor regression grade
determined using the Mandard tumor regression grading system

Full Information

First Posted
November 22, 2017
Last Updated
April 19, 2021
Sponsor
The Netherlands Cancer Institute
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT03448835
Brief Title
Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)
Acronym
PANDA
Official Title
Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer, Gastro Esophageal Junction Cancer
Keywords
short term immunotherapy, surgical resection, atezolizumab, capecitabine, oxaliplatin, docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
single group, open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
atezolizumab and chemotherapy
Arm Type
Experimental
Arm Description
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL3280A
Intervention Description
atezolizumab 1200 mg 5 cycles
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
L01BC06
Intervention Description
capecitabine 850 mg /m2 4 cycles
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
L01XA03
Intervention Description
oxaliplatin 100 mg/m2 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
L01CD02
Intervention Description
docetaxel 50 mg/m2 4 cycles
Primary Outcome Measure Information:
Title
Incidence of adverse events following treatment (safety)
Description
Adverse events will be assessed (according to CTC-AE v4.0) during treatment
Time Frame
until 100 days after last patient last study drug treatment
Secondary Outcome Measure Information:
Title
pathological tumor regression grade
Description
determined using the Mandard tumor regression grading system
Time Frame
Within 6 months after last patient inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: signed informed consent patients age 18 and older primary resectable, histologically confirmed gastric or GEJ adenocarcinoma Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marieke van de Belt
Phone
+3120512
Ext
9111
Email
m.vd.belt@nki.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myriam Chalabi, MD
Organizational Affiliation
Antoni van Leeuwenhoek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marieke van de Belt
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke van de Belt
Phone
+3120512
Ext
1926
Email
m.vd.belt@nki.nl
Facility Name
Catharina ziekenhuis
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G. Nieuwenhuijzen

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35623069
Citation
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.
Results Reference
derived

Learn more about this trial

Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)

We'll reach out to this number within 24 hrs