A PHASE Ib/II STUDY TO EVALUATE SAFETY AND EFFICACY OF ATEZOLIZUMAB COMBINED WITH RADIO-CHEMOTHERAPY IN A PREOPERATIVE SETTING FOR PATIENTS WITH LOCALIZED RECTAL CANCER (R-IMMUNE)
Phase 1
- Conditions
- Rectum cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004526-41-BE
- Lead Sponsor
- Grand hôpital de Charleroi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
•Patient has T3-T4 N0 or T any N1-2, M0, rectal adenocarcinoma
•EGOG performance status 0 or 1
•Patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
Exclusion Criteria
•Patient has locally recurrent or metastatic disease
•Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current rectal cancer disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method