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

Phase 2

• Conditions: Stomach Cancer; Gastro Esophageal Junction Cancer
• Interventions: Drug: Atezolizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Docetaxel

• Registration Number: NCT03448835
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Study Start: 2018-03-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
atezolizumab and chemotherapy	Atezolizumab	1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
atezolizumab and chemotherapy	Capecitabine	1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
atezolizumab and chemotherapy	Oxaliplatin	1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
atezolizumab and chemotherapy	Docetaxel	1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events following treatment (safety)	until 100 days after last patient last study drug treatment	Adverse events will be assessed (according to CTC-AE v4.0) during treatment

Secondary Outcome Measures

Name	Time	Method
pathological tumor regression grade	Within 6 months after last patient inclusion	determined using the Mandard tumor regression grading system

Trial Locations

Locations (2)

Marieke van de Belt; 🇳🇱 Amsterdam, Netherlands

Catharina ziekenhuis; 🇳🇱 Eindhoven, Netherlands