Serplulimab, H101, Radiotherapy, XELOX Phase 2 Rectal Cancer Study (NCT07543848)
Summary
A Phase 2 clinical trial (NCT07543848) registered on ClinicalTrials.gov is evaluating serplulimab (PD-1 inhibitor) combined with oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant treatment for locally advanced low rectal cancer (cT1-3N0M0). The prospective, multicenter, single-arm study will assess the 1-year clinical complete response rate as the primary objective, with secondary outcomes including tumor response rate, organ preservation rate, survival outcomes, and treatment safety.
“This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This is a clinical trial registration entry for NCT07543848, a Phase 2 exploratory study of serplulimab combined with oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy for locally advanced low rectal cancer. The trial is registered as a prospective, multicenter, single-arm study.
For sponsors and clinical investigators, this registration reflects an active Phase 2 oncology study in the neoadjuvant rectal cancer space. The inclusion of intratumoral oncolytic virus injection combined with immunotherapy and chemoradiation represents an integrated total neoadjuvant therapy approach. No compliance obligations or regulatory deadlines arise from this registration entry itself.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer
Phase 2 NCT07543848 Kind: PHASE2 Apr 22, 2026
Abstract
This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).
In this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.
The primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.
The results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.
Conditions: Rectal Neoplasms, Rectal Adenocarcinoma
Interventions: Serplulimab, Oncolytic Virus H101, XELOX Chemotherapy, Short-course Radiotherapy
Mentioned entities
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.