This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Phase 2:Single Group Drug:SHR-1701 30mg/kg,IV ,every 3 week Drug:BP102 7.5mg/kg,IV,every 3 week Drug: Oxaliplatin 130mg/m2 ,IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR,Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
Phase 3:Randomized Drug:SHR-1701 30mg/kg,IV ,every 3 week Drug:BP102 7.5mg/kg,IV,every 3 week Drug: Oxaliplatin 130mg/m2 ,IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR,Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Phase 2:ORR
Objective response rate (assessed by the investigators based on RECIST v1.1)
Time frame: up to 2 years
Phase 2:Incidence of Adverse Events (AEs) by CTCAE v5.0
Assess safety and tolerability of SHR-1701 in combination with BP102 and XELOX
Time frame: up to 2 years
Phase 3:PFS
Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
DCR
Disease control rate,the proportion of patients with the best overall response of CR, PR, or stable disease (SD) 。
Time frame: up to 2 years
OS
Overall survival ,from the date of first dose unitl the date of death from any cause。
Time frame: up to 2 years
PFS
Progression-free survival from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed (assessed by independent radiological review committee (IRRC) based on iRECIST,by the investigators based on RECIST v1.1))。
Time frame: up to 2 years
Duration of response
Duration of response,from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed
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Phase 3:Randomized Drug:Placebo 30mg/kg,IV ,every 3 week Drug:BP102 7.5mg/kg,IV,every 3 week Drug: Oxaliplatin 130mg/m2 ,IV,every 3 week Drug:Capecitabine The total daily dose was 2000mg/m2, OR,Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
Time frame: up to 2 years