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OpenTrials
Active, Not Recruiting

NCT Number: NCT03448835

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stomach Cancer Digestive System Diseases Digestive System Neoplasms Gastro Esophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marieke van de Belt, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

atezolizumab 1200 mg 5 cycles

Other names: MPDL3280A

Capecitabine

Drug

capecitabine 850 mg /m2 4 cycles

Other names: L01BC06

Oxaliplatin

Drug

oxaliplatin 100 mg/m2 4 cycles

Other names: L01XA03

docetaxel

Drug

docetaxel 50 mg/m2 4 cycles

Other names: L01CD02

Primary outcomes

  1. 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

Secondary outcomes

  1. pathological tumor regression grade

    Time frame: Within 6 months after last patient inclusion

    determined using the Mandard tumor regression grading system

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial

Acronym: PANDA

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2018
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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