This is a double-blind, randomized, multi-center, II/III study in at least 606 patients with advanced colorectal cancer. The study is being conducted to evaluate the safety of HR070803 combined with oxaliplatin, 5-FU/LV and bevacizumab in phase II and to evaluate the efficacy of HR070803 in combination with oxaliplatin, 5-FU/LV, and bevacizumab versus HR070803 simulator in combination with FOLFOX and bevacizumab for first-line treatment of patients with unresectable metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
669
HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 8-12 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 8-12 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdog, China
Adverse Events (AE) According to NCI-CTCAE v5.0（Phase II）
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE.
Time frame: From Baseline to primary completion date, about 48 months
Serious Adverse Events (SAE)（Phase II）
An SAE is defined as any of the following adverse events in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment: events that result in death, life-threatening events; events requiring hospitalization or prolonged hospitalization; events leading to permanent or severe disability/loss of function (significant impairment of the ability to carry out normal life functions); congenital abnormalities or birth defects; a medically important event or intervention may be required to prevent any of these outcomes.
Time frame: From Baseline to primary completion date, about 48 months
Progression-Free Survival (PFS) Assessed by IRC（Phase III）
from randomization to PD or death from any cause
Time frame: From Baseline to primary completion date, about 48 months
Overall Response Rate (ORR) Assessed by investigator（Phase II）
The proportion of patients who acquired complete response and partial response during treatment.
Time frame: From Baseline to primary completion date, about 48 months
Disease Control Rate (DCR) by investigator（Phase II）
The proportion of patients who acquired complete response and partial response and stable disease during treatment.
Time frame: From Baseline to primary completion date, about 48 months
Duration of Overall Response (DoR) by investigator（Phase II）
For subjects who demonstrated CR or PR, response duration is defined as the time from the date of first response (CR or PR) until the date of first documented disease progression or death.
Time frame: From Baseline to primary completion date, about 48 months
Progression-Free Survival (PFS) Assessed by investigator（Phase II）
from randomization to PD or death from any cause.
Time frame: From Baseline to primary completion date, about 48 months
Overall Survival (OS)（Phase II）
from randomization to death from any cause.
Time frame: From Baseline to primary completion date, about 48 months
Characterize the PK（Phase II）
Serum concentrations of SN-38 and CPT-11 will be monitored. PK modeling will be performed and an appropriate model will be selected to describe the data.
Time frame: From Baseline to primary completion date, about 48 months
Overall Survival (OS)（Phase III）
from randomization to death from any cause.
Time frame: From Baseline to primary completion date, about 48 months
Progression-Free Survival (PFS) Assessed by investigator（Phase III）
from randomization to PD or death from any cause.
Time frame: From Baseline to primary completion date, about 48 months
Overall Response Rate (ORR) Assessed by IRC and investigator（Phase III）
The proportion of patients who acquired complete response and partial response during treatment.
Time frame: From Baseline to primary completion date, about 48 months
Duration of Overall Response (DoR) by IRC and investigator（Phase III）
For subjects who demonstrated CR or PR, response duration is defined as the time from the date of first response (CR or PR) until the date of first documented disease progression or death.
Time frame: From Baseline to primary completion date, about 48 months
Disease Control Rate（DCR） by IRC and investigator（Phase III）
The proportion of patients who acquired complete response and partial response and stable disease during treatment.
Time frame: From Baseline to primary completion date, about 48 months
Adverse Events (AE) According to NCI-CTCAE v5.0（Phase III）
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE.
Time frame: From Baseline to primary completion date, about 48 months
Serious Adverse Events (SAE)（Phase III）
An SAE is defined as any of the following adverse events in a participant or clinical investigation participant after signing the informed consent form and which does not necessarily have to have a causal relationship with this treatment: events that result in death; life-threatening events; events requiring hospitalization or prolonged hospitalization; events leading to permanent or severe disability/loss of function (significant impairment of the ability to carry out normal life functions); congenital abnormalities or birth defects; a medically important event or intervention may be required to prevent any of these outcomes.
Time frame: From Baseline to primary completion date, about 48 months
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