OncoMatch/Clinical Trials/NCT06542588
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
Is NCT06542588 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06542588 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages