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Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Recurrence and Metastatic Colorectal Cancer

NCT05160727 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-12-20

No results posted yet for this study

Summary

Explore the efficacy of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer patients; To evaluate the safety and tolerability of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer; To evaluate the radiosensitization effects of Tslelizumab and irinotecan;

Conditions

  • Mismatch Repair-proficient
  • Colorectal Cancer Metastatic
  • Microsatellite Stable

Interventions

DRUG

Tislelizumab

200mg ivgtt d1 q3w

DRUG

Irinotecan

Concurrent Chemoradiotherapy: Irinotecan: 80mg/m2/w (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2/w (UGT1A1\*28 and \*6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1\*28 and \*6: 7/7+GG or 6/6+AA or 6/7+GA) Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w.

RADIATION

radiotherapy

radiotherapy

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Ji Zhu, MD · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05160727 on ClinicalTrials.gov