Actively Recruiting
Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Led by Ruijin Hospital · Updated on 2025-09-30
104
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining short-course radiotherapy with CAPOX chemotherapy plus bevacizumab, with or without a PD-1 inhibitor, in patients who have locally advanced rectal cancer (LARC). The study aims to see if adding immunotherapy improves the complete response rate, improves local control, and reduces the chance of cancer spreading. This phase 2 trial compares sequential chemoradiotherapy and targeted therapy with or without immunotherapy to find the best approach for total neoadjuvant therapy in this condition. Participants will receive short-course radiotherapy (25 Gy over 5 fractions), followed by four cycles of the CAPOX regimen, which includes oxaliplatin given intravenously at 130 mg/m² and capecitabine taken orally at 1000 mg/m² for 14 days every three weeks. Bevacizumab is also given intravenously at 7.5 mg/kg on day 1 every three weeks. In one group, patients will also receive a PD-1 inhibitor, toripalimab, given intravenously at 240 mg on day 1 every three weeks. After completing the total neoadjuvant therapy, doctors will decide whether to use a watch-and-wait approach or perform surgery based on tumor response, and whether to give additional chemotherapy after surgery will depend on pathology results. Throughout the study, participants will be closely monitored with imaging and clinical assessments to evaluate tumor response and side effects. The main outcome measured is the complete response rate two weeks after surgery. Researchers will also follow participants for up to 48 months to assess disease-free survival, distant metastasis, local recurrence, overall survival, pathological stage, tumor regression grade, and sphincter preservation rate. The study lasts several years to capture long-term outcomes and safety data.
CONDITIONS
Brief Title
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy
- No BRAF mutations or MSI-H status based on genetic testing; RAS mutation status allowed
- No severe intestinal obstruction symptoms and no distant metastasis by imaging
- Locally advanced rectal cancer confirmed by MRI with specific tumor and lymph node criteria or low-lying rectal cancer unsuitable for sphincter-preserving surgery
- Age between 18 and 75 years
- ECOG Performance Status of 0 to 1 without severe comorbid conditions
- Adequate blood counts, liver and kidney function
- Signed and dated informed consent provided
You will not qualify if you...
- Presence of BRAF mutations or MSI-H status
- Prior chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgery for colorectal cancer
- History or presence of another uncontrolled cancer within 3 years except certain early-stage skin or cervical cancers
- Pregnancy or breastfeeding
- Severe cardiac, liver, kidney, neurological, or psychiatric diseases
- Active infections
- Poor general health with ECOG score 2 or higher
- Organ transplant requiring immunosuppressive therapy or long-term corticosteroids
- Comorbid conditions that risk safety or study completion
- Known allergy to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive short-course radiotherapy followed by 4 cycles of CAPOX combined with Bevacizumab, with or without PD-1 inhibitor immunotherapy as total neoadjuvant therapy for locally advanced rectal cancer.
Multiple visits for radiotherapy and chemotherapy infusions over 12 weeks
Duration - Up to 48 months
Following completion of total neoadjuvant therapy, participants undergo treatment strategy selection based on tumor response, including watch-and-wait or surgical resection, followed by monitoring of outcomes such as recurrence and survival for up to 48 months.
Periodic visits for assessments over 48 months
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
B
Bo Feng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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