Intratumoral H101 plus total neoadjuvant therapy yields pathologic complete response in one patient with metachronous locally advanced rectal cancer.

This case report details the treatment of a single 50-year-old patient diagnosed with metachronous locally advanced rectal cancer harboring a TP53 mutation. The patient received an intratumoral injection of the recombinant human adenovirus H101 in combination with total neoadjuvant therapy. No comparator group was included in this observational study, and the setting was not reported.

At the most recent follow-up, the patient achieved a pathologic complete response (pCR), with absolute numbers of 1 out of 1. Additionally, anal sphincter function was preserved (1 out of 1). There was no evidence of local recurrence (0 out of 1) or distant metastasis (0 out of 1). No adverse events, serious adverse events, discontinuations, or specific tolerability data were reported.

Key limitations include the single-case nature of the report, the absence of a control group, and the lack of statistical measures such as p-values or confidence intervals. The study does not provide evidence regarding the general therapeutic efficacy of combining oncolytic virotherapy with total neoadjuvant therapy in locally advanced rectal cancer. Prior to this report, no clinical data had demonstrated the efficacy of this specific combination in this patient population.

While the practice relevance highlights the potential of oncolytic virotherapy to enhance chemotherapy and radiotherapy effects, clinicians should interpret these results with caution. This approach is not currently a standard treatment option, and the evidence is insufficient to support broad clinical adoption without further validation in larger, controlled trials.