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

Stomach Cancer Clinical Trial

— PANDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448835
• Other study ID #: N17PND
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2021
• Source: The Netherlands Cancer Institute
• Contact: Marieke van de Belt
• Phone: +3120512
• Email: m.vd.belt[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Junction Cancer
• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• Atezolizumab
atezolizumab 1200 mg 5 cycles
• Capecitabine
capecitabine 850 mg /m2 4 cycles
• Oxaliplatin
oxaliplatin 100 mg/m2 4 cycles
• Docetaxel
docetaxel 50 mg/m2 4 cycles

Locations

Country	Name	City	State
Netherlands	Marieke van de Belt	Amsterdam
Netherlands	Catharina ziekenhuis	Eindhoven

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pathological tumor regression grade	determined using the Mandard tumor regression grading system	Within 6 months after last patient inclusion