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RECRUITING
NCT06848465
PHASE1

LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis

Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

View on ClinicalTrials.gov

Summary

In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.

Official title: A Phase Ib Trial on the Safety and Feasibility of Low Dose Radiotherapy (LDRT) Combined With Immunochemotherapy for Colorectal Cancer With Liver-limited Metastasis

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2025-02-28

Completion Date

2027-11-30

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

RADIATION

Low Dose Radiotherapy

10 Gy in 5 fractions, 15 Gy in 3 fractions, 20 Gy in 10 fractions respectively in three Cohorts from Day1

RADIATION

Short course Radiotherapy

25 Gy in 5 fractions from Day1

DRUG

XELOX

Oxaliplatin: 130mg/m2 IV Q3W on day 1 of each cycle. Capecitabine: 1000mg/m2 Q3W Dose of 1000mg/m2 on day 1-14 of each cycle.

DRUG

Tislelizumab

200mg IV Q3W on day 1 of each cycle.

Locations (2)

Army Medical Center

Chongqing, Chongqing Municipality, China

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, China