Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- clinical complete and near-complete response rate
Study Overview
Brief Summary
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab
Detailed Description
38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •signed informed consent
- •patients age 18 years and older
- •histologically confirmed adenocarcinoma of the rectum
- •intermediate risk rectal cancer or low risk distal rectal cancer
Exclusion Criteria
- •evidence of metastatic disease
- •prior radiation therapy for disease under study
- •prior treatment with CD137 agonists or immune checkpoint blockade therapies
- •current or recent use of acetylsalicylic acid
- •history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding
- •significant auto-immune disease
Arms & Interventions
bevacizumab and atezolizumab
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
Intervention: Atezolizumab (Drug)
bevacizumab and atezolizumab
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
Intervention: Bevacizumab (Drug)
Outcomes
Primary Outcomes
clinical complete and near-complete response rate
Time Frame: 12 weeks post-radiotherapy
response rate will be assessed by MRI and endoscopy
Secondary Outcomes
- local recurrence rate at 1 year follow-up(1 year post-radiotherapy)
- incidence of adverse events following treatment (safety)(untill 100 days after last patient last study drug)