The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

Sponsor
Fujian Cancer Hospital
Study ID
NCT05640726
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PD-1 — DRUG
    Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
  • SCRT — RADIATION
    Radiotherapy dose: 5×5 Gy
  • Bevacizumab — DRUG
    Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks
  • Oxaliplatin — DRUG
    Participants will receive Oxaliplatin，85mg/m2，day1
  • Calcium folinate — DRUG
    Participants will receive calcium folinate ，400mg/m2，day1
  • 5-fluorouracil — DRUG
    Participants will receive 5-fluorouracil ，400mg/m2，day1

Study Details

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

Key Dates

First listed
Dec 7, 2022
Start date
May 1, 2023
Status verified
Nov 2022
Primary completion
May 1, 2024
Completion
May 1, 2026

Study Design

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

Arms

  • Experimental: (SCRT) followed by PD-1+ standard therapy

Primary Outcome Measure

progression free survival [ Time Frame: up to 36 months ]

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