QL1706 Injection Plus Bevacizumab and XELOX vs Placebo Plus Bevacizumab and XELOX as First-Line Treatment of Unresectable Metastatic Colorectal Cancer

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07025239
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • QL1706 — DRUG
    QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of QL1706 lasts for up to 2 years.
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion at 7.5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Bevacizumab lasts for up to 2 years.
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered by IV infusion at 130 mg/m2 on Day 1 of each 21-day cycle up to 8 treatment cycles.
  • Capecitabine — DRUG
    Capecitabine will be administered orally at 1000 mg/m2 twice daily for 2 consecutive weeks, followed by one-week rest in each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Capecitabine lasts for up to 2 years.
  • Placebo — DRUG
    Placebo will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Placebo lasts for up to 2 years.

Study Details

The purpose of this study is to evaluate the efficacy and safety of QL1706 Injection in combination with bevacizumab and XELOX compared with placebo in combination with bevacizumab and XELOX for first-line treatment in patients with unresectable mCRC.

Key Dates

First listed
Jun 17, 2025
Start date
Jul 31, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706 + bevacizumab + XELOX
  • Placebo Comparator: Placebo+ bevacizumab + XELOX

Primary Outcome Measure

Progression Free Survival (PFS) Assessed by the Independent Radiology Review Committee (IRRC) [ Time Frame: Up to approximately 2 years ]

Central Contacts

Related Studies