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New treatment option for Colorectal Cancer
Official title A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT07604909
What this study is testing
What is Serplulimab?
Serplulimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
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
- Approximately 20-50% of patients with colorectal cancer (CRC) develop distant metastasis after curative surgery, and those with early relapse within one year of completing adjuvant chemotherapy (XELOX or FOLFOX) have a particularly poor prognosis and limited treatment options. Standard second-line therapy with FOLFIRI plus targeted therapy (bevacizumab or cetuximab) often yields suboptimal outcomes in this population.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, male or female. Histologically confirmed early relapse (within 1 year after surgery, UICC stage IV) of colorectal cancer after...
- Neutrophils ≥1.5 × 10⁹/L; platelets ≥100 × 10⁹/L; hemoglobin ≥9 g/dL; serum albumin ≥3 g/dL.
- Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN), with T3 and T4 within normal range.
- Bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN.
- Serum creatinine ≤1.5 × ULN, creatinine clearance ≥60 mL/min.
You likely can't join if
- Pathologically diagnosed other intestinal tumors, such as gastrointestinal stromal tumors.
- RAS mutation status not tested. Tumor tissue tested by immunohistochemistry as dMMR, or by PCR or NGS as MSI-H. Metastatic lesions are resectable, or...
- Uncontrolled active bleeding from the primary tumor or intestinal obstruction. Contraindications to immune checkpoint inhibitor therapy...
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis...
- History of immunodeficiency, including HIV positivity, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation...
- History of interstitial lung disease or non-infectious pneumonitis. Active pulmonary tuberculosis infection by history or CT scan, or history of...
See the full eligibility criteria
- Age ≥18 years, male or female. Histologically confirmed early relapse (within 1 year after surgery, UICC stage IV) of colorectal cancer after adjuvant chemotherapy, with initially unresectable metastatic lesions or...
- Neutrophils ≥1.5 × 10⁹/L; platelets ≥100 × 10⁹/L; hemoglobin ≥9 g/dL; serum albumin ≥3 g/dL.
- Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN), with T3 and T4 within normal range.
- Bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN.
- Serum creatinine ≤1.5 × ULN, creatinine clearance ≥60 mL/min.
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN, unless the patient is receiving anticoagulant therapy and PT is within the expected therapeutic range for anticoagulation.
- Activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Female patients of childbearing potential must have a negative pregnancy test. Female patients not of childbearing potential, fertile male patients, and female...
- Pathologically diagnosed other intestinal tumors, such as gastrointestinal stromal tumors.
- RAS mutation status not tested. Tumor tissue tested by immunohistochemistry as dMMR, or by PCR or NGS as MSI-H. Metastatic lesions are resectable, or the patient wishes to undergo metastasectomy.
- Uncontrolled active bleeding from the primary tumor or intestinal obstruction. Contraindications to immune checkpoint inhibitor therapy. Hypersensitivity to study drugs or their excipients. Prior or concurrent other...
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these...
- History of immunodeficiency, including HIV positivity, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- History of interstitial lung disease or non-infectious pneumonitis. Active pulmonary tuberculosis infection by history or CT scan, or history of active pulmonary tuberculosis infection within 1 year before enrollment...
- Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).
- Severe cardiac, pulmonary, renal, or hepatic dysfunction. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- History of psychotropic substance abuse, alcoholism, or drug addiction. Other factors that may affect patient safety or trial compliance as judged by the investigator, such as serious diseases requiring concomitant...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.