Actively Recruiting
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
Led by Ruijin Hospital · Updated on 2025-09-30
104
Participants Needed
1
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.
CONDITIONS
Official 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 as confirmed by genetic testing; RAS mutation status allowed
- No severe intestinal obstruction symptoms and no distant metastasis confirmed by imaging
- Locally advanced rectal cancer confirmed by MRI with criteria including T3c-d or T4 stage, N2, EMVI(+), MRF(+), lateral lymph node metastasis, or low-lying rectal cancer (≤5 cm from anal verge) unsuitable for sphincter-preserving surgery
- Age between 18 and 75 years
- ECOG Performance Status 0 to 1 without severe comorbid medical conditions
- Adequate organ function: Hemoglobin ≥90 g/L, Platelets ≥80 x 10^9/L, Absolute Neutrophil Count ≥1.5 x 10^9/L; ALT and AST < 2.5 x ULN; Serum Creatinine < 1.5 x ULN
- Signed and dated written informed consent
You will not qualify if you...
- Presence of BRAF mutations or MSI-H status
- Prior chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer
- History or current other malignancy within past 3 years, except early-stage basal cell carcinoma or carcinoma in situ of cervix
- Pregnant or breastfeeding women
- Severe cardiac, hepatic, renal, neurological, or psychiatric diseases
- Active infections
- ECOG performance status ≥2
- Organ transplantation requiring immunosuppressive therapy or long-term corticosteroid treatment for autoimmune diseases
- Comorbid conditions that may endanger safety or study completion
- Known hypersensitivity to any study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
B
Bo Feng
CONTACT
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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