EUCTR2019-003865-17-AT
Active, not recruiting
Phase 1
eoadjuvant CHemoradiotherapy with sequential Ipilimumab and NivOlumab in RECtal cancer (CHINOREC): a prospective randomized, open-label, multicenter, phase II clinical trial
Conditions• Histologically confirmed carcinoma of the rectum• Suitable for local therapy with curative intent• Medical need for a standard neoadjuvant CRT• Suitable to withstand a course of standard neoadjuvant CRTMedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10038045Term: Rectal cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- • Histologically confirmed carcinoma of the rectum• Suitable for local therapy with curative intent• Medical need for a standard neoadjuvant CRT• Suitable to withstand a course of standard neoadjuvant CRT
- Sponsor
- Medizinische Universität Wien
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age and older
- •All sexes
- •Histologically confirmed carcinoma of the rectum
- •Suitable for local therapy with curative intent
- •Medical need for a standard neoadjuvant CRT
- •Suitable to withstand a course of standard neoadjuvant CRT
- •Written informed consent form (ICF) for participation in the study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Metastatic disease that is considered incurable by local therapies
- •Previous surgery of the tumor other than biopsy
- •Pregnancy, breastfeeding or expectancy to conceive
- •Disagreement of participants with reproductive potential to use
- •contraception throughout the study period and for up to 180 days
- •after the last dose of study therapy
- •Prior therapy with anti\-CTLA\-4, anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2 or
- •any other agent directed against co\-inhibitory T cell receptors or
- •has previously participated in clinical studies with immunotherapy
- •Any contraindication according to the official medical information
Outcomes
Primary Outcomes
Not specified
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