CRC
Conditions
Brief 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.
Interventions
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age\>=18Y and ≤75Y * Good Organ Function * Expected survival time ≥ 3 months * mCRC that have been diagnosed histologically * KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue * ECOG score 0-1;
Exclusion criteria
* HIV infection * Active clinical severe infection; * A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 3 years | Objective response rate (assessed by investigator per RECIST V1.1) |
| PFS | : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years | Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 5 years | Overall Survival |
Contacts
Primary ContactPeng Junjie
Outcome results
None listed