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

NCT07025239 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2025-06-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

QL1706

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.

DRUG

Bevacizumab

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.

DRUG

Oxaliplatin

Oxaliplatin will be administered by IV infusion at 130 mg/m2 on Day 1 of each 21-day cycle up to 8 treatment cycles.

DRUG

Capecitabine

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-07-31
Completion
2029-07-31

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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 NCT07025239 on ClinicalTrials.gov