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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05160727
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    200mg ivgtt d1 q3w
  • Irinotecan — DRUG
    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.
  • radiotherapy — RADIATION
    radiotherapy

Study Details

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;

Key Dates

Start date
Oct 1, 2021
Status verified
Dec 2021
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Concurrent Chemoradiotherapy: Radiation: The dose is determined according to the treatment site and the purpose of treatment. 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) Tislelizumab: 200mg ivgtt d1 q3w Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w. Tislelizumab: 200mg ivgtt d1 q3w. Efficacy assessment every 3 cycles.

Primary Outcome Measure

Objective response rate [ Time Frame: 18 weeks after treatment completion ]

Central Contacts

Related Studies