Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
NCT05239650 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-05-03
Summary
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.
Conditions
Interventions
- DRUG
-
HLX07
1000mg
- DRUG
-
HLX10
200mg
- DRUG
-
OXA:85 mg/m2;LV:400 mg/m2;5-FU:400 mg/m2
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Peng Junjie · Fudan University Affiliated Oncology Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-15
- Primary Completion
- 2025-10-15
- Completion
- 2026-10-15
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