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High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM

NCT06045286 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-21

No results posted yet for this study

Summary

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.

Conditions

  • Colorectal Liver Metastases

Interventions

RADIATION

Radiation: High- and Low-dose radiotherapy

High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion.

DRUG

PD-1 Inhibitors

Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-09-30
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT06045286 on ClinicalTrials.gov