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SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer

NCT07297030 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-12-22

No results posted yet for this study

Summary

The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.

Conditions

Interventions

RADIATION

SIB-SCRT

The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.

DRUG

CAPOX

* Oxaliplatin 130 mg/m² intravenously on day 1. * Capecitabine 1,000 mg/m² orally twice daily on days 1-14.

DRUG

Immunotherapy

\- Tislelizumab 200 mg intravenously on day 1.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2026-05-31
Completion
2029-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07297030 on ClinicalTrials.gov