OncoMatch/Clinical Trials/NCT04547166
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab(HLX10) Combined With Bevacizumab(HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
Is NCT04547166 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including HLX10 and HLX04、 for metastatic colorectal cancer.
Treatment: HLX10 · HLX04、 — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MSH2 MSI-H
Have confirmed MSI-H CRC (gene test)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor drug treatment
Exception: neoadjuvant/adjuvant therapy completed >12 months before recurrence/progression
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.
Cannot have received: radiotherapy
Exception: palliative radiotherapy for bone disorders at least 14 days prior to initiation of study treatment
Have received radiotherapy within 6 months prior to the initiation of study treatment, except for palliative radiotherapy for bone disorders at least 14 days prior to initiation of study treatment; radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not allowed.
Cannot have received: major surgery
Have received major surgery within 28 days prior to randomization. A major surgery in this study is defined as a surgery requiring at least 3 weeks of recovery to be able to receive the treatment in this study
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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