MedTrace Logo

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

NCT07543848 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-22

No results posted yet for this study

Summary

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

DRUG

XELOX Chemotherapy

XELOX chemotherapy consists of oxaliplatin and capecitabine. Oxaliplatin will be administered intravenously at a dose of 130 mg/m² on Day 1, and capecitabine will be given orally at a dose of 1000 mg/m² twice daily from Day 1 to Day 14 of each 3-week cycle. A total of 6 cycles will be administered. Chemotherapy is combined with immunotherapy, radiotherapy, and oncolytic virus therapy to improve tumor response.

RADIATION

Short-course Radiotherapy

Short-course radiotherapy will be delivered to the rectal tumor using intensity-modulated radiation therapy (IMRT). The total dose is 25 Gy administered in 5 fractions over one week. Radiotherapy is given during the treatment course in combination with immunotherapy, chemotherapy, and oncolytic virus therapy. It aims to enhance local tumor control and stimulate anti-tumor immune response.

BIOLOGICAL

Oncolytic Virus H101

H101 is a recombinant human adenovirus type 5 oncolytic virus that selectively replicates in and lyses tumor cells while stimulating anti-tumor immune responses. It will be administered by intratumoral injection on Day 1 of Cycle 1 and Day 1 of Cycle 4. The dose will be determined based on tumor size. H101 is used in combination with immunotherapy, chemotherapy, and radiotherapy to enhance tumor cell killing and improve immune activation.

DRUG

Serplulimab

Serplulimab is a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1). It will be administered intravenously at a fixed dose of 300 mg on Day 1 of each 3-week cycle for a total of 6 cycles. Serplulimab is given in combination with chemotherapy, radiotherapy, and oncolytic virus therapy as part of total neoadjuvant treatment. The aim is to enhance anti-tumor immune response and improve treatment efficacy.

Sponsors & Collaborators

  • Chongqing University Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543848 on ClinicalTrials.gov