Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

Sponsor
Jinan Central Hospital
Study ID
NCT07116577
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • mCRC

Eligibility Criteria

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

Interventions

  • Palliative radiotherapy — RADIATION
    Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
  • Iparomlimab and tuvonralimab — DRUG
    5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
  • TAS-102 — DRUG
    35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).
  • Bevacizumab — DRUG
    7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Study Details

This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.

Key Dates

First listed
Aug 11, 2025
Start date
Aug 31, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Experimental Arm
    Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.

Primary Outcome Measure

ORR [ Time Frame: approximately 4 months after the last subject participating in ]

Central Contacts

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