A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)
This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)
• Histopathologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma
• Life expectancy ≥ 12 weeks
• Have not received any previous systemic anti-tumor drug treatment for metastatic colorectal adenocarcinoma
• For participants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to recurrence or progression must exceed 12 months.
• With at least one measurable lesion as assessed by the IRRC per RECIST v1.1, and the measurable lesion should not have been treated locally such as with radiotherapy (a lesion located in an area subjected to previous radiotherapy can also be regarded as a measurable lesion if PD is confirmed)
• Agree to provide sufficient previously preserved tumor tissue specimens or agree to undergo biopsy to collect tumor tissue for some gene test.
• Have an ECOG PS score of 0 or 1 within 7 days prior to receiving the first dose of the study drugs
• Have Adequate major organ functions.