What question did this study set out to answer?

This research aims to compare the efficacy and toxicity of neoadjuvant therapy using camrelizumab plus FOLFOXIRI against FOLFOXIRI alone in locally advanced rectal cancer.

April 6, 2026npj Precision Oncology0 citationsOpen Access

Neoadjuvant FOLFOXIRI chemotherapy with or without camrelizumab in the treatment of locally advanced rectal cancer: a retrospective cohort study

YLYanlong LiuHarbin Medical University SZShihui ZhaoHarbin Medical University FDFenqi Du

Key Points

This research aims to compare the efficacy and toxicity of neoadjuvant therapy using camrelizumab plus FOLFOXIRI against FOLFOXIRI alone in locally advanced rectal cancer.
Retrospective cohort study
Comparative analysis of two treatment groups: camrelizumab plus modified FOLFOXIRI versus modified FOLFOXIRI alone
Participants had clinical stage II-III locally advanced rectal cancer and received ≥3 cycles of therapy
Outcomes assessed include pathological complete response rates, objective response rates, and toxicity profiles
Pathological complete response rates were 29.8% for camrelizumab plus FOLFOXIRI and 19.6% for FOLFOXIRI alone
Radiologic objective response rates were 70.7% for camrelizumab plus FOLFOXIRI and 53.5% for FOLFOXIRI alone
Mean neoadjuvant rectal scores were significantly lower with camrelizumab (13.95) compared to FOLFOXIRI alone (23.77; P < 0.02)
Disease-free survival was significantly improved in the camrelizumab group while overall survival was similar at the follow-up
Grade 3–4 hematologic and gastrointestinal toxicities were comparable between both groups

Abstract

Standard neoadjuvant chemoradiotherapy for locally advanced rectal cancer (LARC) is associated with significant toxicity and limited pathological responses. We retrospectively compared a radiotherapy‑free regimen of camrelizumab plus modified FOLFOXIRI versus modified FOLFOXIRI alone in consecutive patients with clinical stage II–III LARC treated from 2022–2025 (n = 146). All patients received ≥3 cycles of neoadjuvant therapy; surgery or watch‑and‑wait was determined by a multidisciplinary team. Baseline characteristics were well balanced. Among surgical patients, pCR rates were 29.8% with camrelizumab plus FOLFOXIRI and 19.6% with FOLFOXIRI alone. Radiologic objective response rates were 70.7% and 53.5%, respectively, and mean neoadjuvant rectal scores were lower with camrelizumab (13.95 vs 23.77; P < 0.02). Disease‑free survival was significantly improved in the camrelizumab group, while overall survival was similar at current follow‑up. Grade 3–4 hematologic and gastrointestinal toxicities were comparable, and no unexpected immune‑related events occurred. Camrelizumab plus FOLFOXIRI appears to be an active, tolerable radiotherapy‑free neoadjuvant option for LARC.

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