Study on the treatment of patients with gastroesophageal cancer with chemotherapy and immunotherapy based on a non-functioning DNA mismatch repair mechanism in the tumour cells

Phase 1

• Conditions: Gastroesophageal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001181-38-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-26
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- Male or female adult patients (> 18 years)
- Primaire tumor or metastasis accessible for repeat fresh histological biopsies
- dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2, and MSH6
- Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligble when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease
- Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligble for evaluation are present
- Measurable disease as assessed by RECIST 1.1
- ECOG (WHO) performace status 0-2
- Patient has adequate hepatic, renal and hematological function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Past or current malginancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified