OncoMatch/Clinical Trials/NCT07198165
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
Is NCT07198165 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PD-1 inhibitor based immunotherapy for rectal cancer.
Treatment: PD-1 inhibitor based immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF mutation
Exclusion of patients with BRAF mutations ... Patients found to have BRAF mutations ... are excluded
Required: MSH2 MSI-H
Exclusion of patients with ... MSI-H status ... Patients found to have ... MSI-H status are excluded
Required: MSH6 MSI-H
Exclusion of patients with ... MSI-H status ... Patients found to have ... MSI-H status are excluded
Required: MLH1 MSI-H
Exclusion of patients with ... MSI-H status ... Patients found to have ... MSI-H status are excluded
Required: PMS2 MSI-H
Exclusion of patients with ... MSI-H status ... Patients found to have ... MSI-H status are excluded
Disease stage
Required: Stage T3C-D
Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Cannot have received: radiotherapy
Cannot have received: immunotherapy
Cannot have received: targeted therapy
Cannot have received: surgical resection
Lab requirements
Blood counts
hemoglobin ≥90 g/l, platelets ≥80 × 10^9/l, absolute neutrophil count ≥1.5 × 10^9/l
Kidney function
serum creatinine < 1.5 × uln
Liver function
alt and ast < 2.5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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