Colorectal Cancer Treatments and Studies / Colorectal Cancer Surgical Treatments / Genetic Factors in Colorectal Cancer · Journal article
Signal Transduction and Targeted Therapy · August 18, 2026
Encouraging direction, but not yet definitive.
This single-center phase 2 trial demonstrates that biomarker-driven total neoadjuvant therapy with targeted agents achieves a 40% complete response rate in high-risk locally advanced rectal cancer with acceptable safety. The result is promising but requires confirmation in a controlled, multi-center trial before clinical recommendations can be made.
Multicohort, single-center, phase 2 trial. High-risk locally advanced rectal cancer patients; 96 enrolled, 90 completed treatment; single-center setting (location not specified).. Intervention: Induction mFOLFOX6 + targeted agent (bevacizumab or cetuximab), short-course radiotherapy (25 Gy/5Fx), and consolidation mFOLFOX6 ± cetuximab. n = 90. Single center (country and institution not stated in abstract).
Complete response (sustained clinical CR + pathological CR) achieved in 36 of 90 patients (40%) No grade IV-V toxicity observed; 3 patients in cohort B and 41 patients in cohort C experienced targeted agent-related adverse effects Sphincter preservation achieved in 39 of 43 patients (90.7%) in cohort B and 34 of 38 patients (89.5%) in cohort C
High rate of targeted agent-related adverse effects in cohort C (41/81 patients, 50.6%) limits comparative interpretation between cohorts. No grade IV-V toxicity observed; 3 patients in cohort B and 41 patients in cohort C experienced targeted agent-related adverse effects
If confirmed in multi-center trials, this biomarker-driven neoadjuvant approach with targeted agents could improve complete response rates and sphincter preservation in high-risk rectal cancer. Clinicians should view this as hypothesis-generating; implementation outside clinical trials is not yet justified.
A single-center phase 2 trial with a meaningful primary endpoint (40% complete response) and acceptable safety, but limited by lack of control group, modest sample size, and single-center design requiring confirmation in larger studies.
As stated by the source record.
Quoted from the source exactly as published.
If confirmed in multi-center trials, this biomarker-driven neoadjuvant approach with targeted agents could improve complete response rates and sphincter preservation in high-risk rectal cancer. Clinicians should view this as hypothesis-generating; implementation outside clinical trials is not yet justified.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This multicohort, single-center, phase II trial explored the efficacy and safety of a biomarker-driven total neoadjuvant therapy (TNT) regimen in high-risk locally advanced rectal cancer (LARC) patients. The regimen included induction chemotherapy (4 cycles of mFOLFOX6) with targeted agents (bevacizumab for cohort B and cetuximab for cohort C), followed by short-course radiotherapy (25 Gy/5Fx) and consolidation chemotherapy (2 cycles of mFOLFOX6, with cetuximab in cohort C). The primary endpoint was complete response (CR; sustained clinical CR [cCR] + pathological CR [pCR]). Secondary endpoints included compliance, safety, pathological outcomes, and survival. Between April 2021 and October 2024, 90 of 96 patients completed the prescribed treatment. CR was achieved in 36 (18 in cohort B and 18 in cohort C) patients (40%). No grade IV-V toxicity was observed, although three and 41 patients experienced targeted agent-related adverse effects in cohort B and C, respectively. In the two cohorts, 43 and 38 patients underwent curative surgery with sphincter preservation in 39 (90.7%) and 34 (89.5%) patients, respectively. Postoperative complications occurred in seven (16.3%) and five (13.2%) patients, of whom one (2.6%) patient in cohort C received reoperation. This intensified TNT regimen with targeted agents for high-risk LARC patients achieved a satisfactory CR rate with acceptable toxicities and complications.
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