QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
NCT05799820 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-05-25
Summary
This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.
Conditions
- Colorectal Carcinoma
Interventions
- DRUG
-
QL1706
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
- DRUG
-
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
- DRUG
-
Oxaliplatin injection
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
- DRUG
-
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jin Li, MD · Shanghai East Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-29
- Primary Completion
- 2024-03-30
- Completion
- 2025-09-30
Countries
- China
Study Locations
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