OncoMatch/Clinical Trials/NCT06542588
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
Is NCT06542588 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody) for rectal cancer.
Treatment: HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody) — The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF wild-type
Required: KRAS wild-type
Required: NRAS wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc
Cannot have received: chemotherapy
Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc
Cannot have received: surgery
Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc
Lab requirements
Blood counts
WBC ≥ 4×10^9/L; ANC ≥ 1.5×10^9/L; Platelet count ≥ 100×10^9/L; Hemoglobin ≥90 g/L
Kidney function
Serum creatinine ≤1.5 × ULN or creatinine clearance rate ≥50 mL/min
Liver function
Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×10^9/L; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelet count ≥ 100×10^9/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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