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New treatment option for Colorectal Carcinoma
Official title SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases
ClinicalTrials.gov ID: NCT06850103
What this study is testing
What is CAPEOX/XELOX?
CAPEOX/XELOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- \- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.
- Age between 18-75 years.
- Histologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.
- Synchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.)...
- Microsatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or...
You likely can't join if
- \- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.
- Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or 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...
- Concurrent participation in another clinical trial, except for observational (non-treatment) studies or survival follow-up phase of treatment studies.
- Receipt of any investigational drug within 4 weeks prior to first dose of study drug.
- History of blood transfusion or use of G-CSF, GM-CSF, EPO, TPO, or IL-11 within 14 days prior to screening laboratory tests.
See the full eligibility criteria
Who can join
- \- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.
- Age between 18-75 years.
- Histologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.
- Synchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions.
- Microsatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry...
- At least one measurable lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- Adequate organ function and bone marrow reserve, defined as follows:
- Complete blood count:
- Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet count (PLT) ≥100×109/L Hemoglobin (HGB) ≥10.0g/dL
- Liver function:
- Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (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 [see Appendix 3] or standard 24-hour urine collection method) Urine protein by dipstick \<2+ For people with...
- Coagulation:
- International Normalized Ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Certain anticoagulant medications (such as antiplatelet agents, vitamin K antagonists) must be discontinued 7-14 days...
- Women of childbearing potential and men whose partners are of childbearing potential must use effective contraception during the entire treatment period and for 6 months after treatment completion. Female people must...
What rules you out
- \- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.
- Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or 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.
- Concurrent participation in another clinical trial, except for observational (non-treatment) studies or survival follow-up phase of treatment studies.
- Receipt of any investigational drug within 4 weeks prior to first dose of study drug.
- History of blood transfusion or use of G-CSF, GM-CSF, EPO, TPO, or IL-11 within 14 days prior to screening laboratory tests.
- Use of immunosuppressive medications within 4 weeks prior to first dose of study drug, excluding:
- Intranasal inhaled corticosteroids or local steroid injections Systemic corticosteroids at ≤10 mg/day prednisone equivalent Corticosteroids as premedication for allergic reactions (e.g., CT contrast) Traditional Chinese...
- Major surgery within 4 weeks prior to first dose (e.g., craniotomy, thoracotomy, or laparotomy), anticipated major surgery during treatment (excluding protocol-specified rectal cancer surgery), or presence of unhealed...
- Known active or suspected autoimmune disease or history within past 2 years (exceptions: eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in past 2 years; hypothyroidism...
- Known history of primary immunodeficiency.
- Active tuberculosis, current anti-TB treatment, or anti-TB treatment within 1 year prior to first dose.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known allergy to capecitabine, oxaliplatin, serplulimab, or other monoclonal antibody components.
- Clinically significant ascites, pleural effusion requiring intervention, or symptomatic pericardial effusion requiring drainage.
- HIV infection (HIV antibody positive).
- Acute or chronic active hepatitis B (defined as HBsAg positive or HBcAb positive only with HBV DNA ≥2000 IU/mL or ≥1×104 copies/mL) or hepatitis C (defined as HCV antibody positive with detectable HCV RNA).
- Active syphilis infection requiring treatment.
- Severe infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or IV antibiotics within two weeks prior to first dose.
- Symptomatic congestive heart failure (NYHA class II-IV) or LVEF \ 500 ms at screening (Fridericia's formula).
- Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite standard therapy, history of hypertensive crisis or encephalopathy.
- Severe bleeding diathesis or coagulation disorders, or current thrombolytic therapy.
- Any arterial thromboembolic events within 6 months prior to first dose, including myocardial infarction, unstable angina, stroke, or TIA.
- Esophageal or gastric varices requiring immediate intervention; high bleeding risk people require endoscopic evaluation within 3 months before enrollment.
- History of GI perforation and/or fistula within 6 months prior to first dose.
- Life-threatening bleeding event within 3 months prior to first dose, or Grade 3/4 GI/variceal bleeding requiring transfusion, endoscopy, or surgery.
- History of DVT, PE, or other serious thromboembolism within 3 months prior to first dose (excluding catheter-related thrombosis or superficial thrombosis).
- Uncontrolled metabolic disorders or other non-malignant conditions causing high medical risk or uncertain survival evaluation.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B \>7 or worse cirrhosis.
- Bowel obstruction (including incomplete requiring parenteral nutrition); conditions with perforation risk; history of extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Interstitial lung disease requiring treatment; history of pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, organizing pneumonia, or severe pulmonary dysfunction.
- Significant malnutrition (5% weight loss within 1 month or 15% within 3 months of consent, or \>50% reduced intake for 1 week), unless corrected for ≥4 weeks before first dose.
- History of other primary malignancies, except:
- Cured malignancies with ≥2 years disease-free and low recurrence risk Well-treated non-melanoma skin cancer or lentigo maligna Well-treated carcinoma in situ
- Other acute or chronic conditions that could:
- Increase study participation risks Interfere with result interpretation Make subject unsuitable per investigator judgment Neurological, psychiatric, or social conditions affecting compliance or safety assessment.
- Alcohol, drug, or substance abuse affecting drug administration or toxicity analysis.
- Pregnant or breastfeeding women.
- Conditions interfering with medication management or toxicity analysis due to alcohol, drug, or substance use.
- Pregnancy or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.