OncoMatch/Clinical Trials/NCT06850103
SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases
Is NCT06850103 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CAPEOX/XELOX and Serplulimab for colorectal carcinoma.
Treatment: CAPEOX/XELOX · Serplulimab — Background and Significance: Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs. Current Treatment Landscape: The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM). Treatment Evolution and Challenges: While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence. Innovative Approach: Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments. Research Objective: This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population. Research Innovation: The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSI microsatellite stable
Microsatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250)
Required: MMR proficient mismatch repair (positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2))
proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Cannot have received: radiotherapy
Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Cannot have received: chemotherapy
Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Cannot have received: targeted therapy
Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Cannot have received: immunotherapy
Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Cannot have received: anti-PD-1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
Cannot have received: anti-PD-L1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
Cannot have received: anti-PD-L2 therapy
Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
Cannot have received: anti-CTLA-4 therapy
Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
Cannot have received: adoptive cell immunotherapy
Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Hemoglobin ≥10.0g/dL
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min; Urine protein by dipstick <2+; if ≥2+, 24-hour urine protein must be <1g
Liver function
Total Bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤3×ULN; Serum albumin (ALB) ≥35 g/L
Adequate organ function and bone marrow reserve, defined as follows: Complete blood count: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L Platelet count (PLT) ≥100×10^9/L Hemoglobin (HGB) ≥10.0g/dL Liver function: Total Bilirubin (TBIL) ≤1.5×ULN Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN Serum albumin (ALB) ≥35 g/L Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated using Cockcroft-Gault formula or standard 24-hour urine collection method) Urine protein by dipstick <2+ For subjects with baseline urine protein ≥2+ by dipstick, 24-hour urine protein must be <1g
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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