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

Netherlands Cancer Institute (NKI) logo

Netherlands Cancer Institute (NKI)

Status and phase

Unknown
Phase 2

Conditions

Gastro Esophageal Junction Cancer
Stomach Cancer

Treatments

Drug: Docetaxel
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Atezolizumab

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

atezolizumab and chemotherapy
Experimental group
Description:
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
Treatment:
Drug: Atezolizumab
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Docetaxel

Trial contacts and locations

2

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Central trial contact

Marieke van de Belt

Data sourced from clinicaltrials.gov

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