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New treatment option for Colo-rectal Cancer
Official title Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC
ClinicalTrials.gov ID: NCT07003022
What this study is testing
What is cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib.?
cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib. is an investigational medicine, being studied as a potential treatment for colo-rectal 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
- This study is a prospective, open-label, dual-arm exploratory Phase II clinical trial designed to assess the efficacy and safety of cadonilimab combined with anti-angiogenic agents in patients with dMMR/MSI-H recurrent or metastatic colorectal cancer. Eligible patients are enrolled into two cohorts based on their prior exposure to PD-1/PD-L1 antibody therapy: Cohort A (immune-naive group - patients with no prior PD-1/PD-L1 treatment) and Cohort B (immune rechallenge group - patients who previously received and failed PD-1/PD-L1 therapy).
- 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 80
You may be able to join if
- \- Signed written informed consent prior to enrollment. Age 18-80 years. dMMR or MSI-H Diagnosis confirmed by histological examination and/or...
- ECOG score: 0 to 2. At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan...
- Adequate organ function with. Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelets (Platelet, PLT) ≥ 100 × 109/L, Hemoglobin (HGB) ≥...
- Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST)...
- Renal function: Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/mi (applying the standard Cockcroft-Gault formula).
You likely can't join if
- Symptomatic brain metastases. A prior history of a primary tumor outside of the colorectal cancer in 3 years Active autoimmune disease or autoimmune...
- people with any severe and/or uncontrolled disease. including. Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic...
- Those with renal failure requiring hemodialysis or peritoneal dialysis. Those with a history of immunodeficiency, including HIV-positive or suffering...
- Research treatment related to. Patients who have undergone major organ transplantation Those who have undergone major surgical treatment, incisional...
- Those with a history of severe allergy. Women who are pregnant or breastfeeding At risk for bleeding, or with coagulation disorders, or undergoing...
See the full eligibility criteria
- \- Signed written informed consent prior to enrollment. Age 18-80 years. dMMR or MSI-H Diagnosis confirmed by histological examination and/or cytological examination combined with imaging assessment of advanced...
- ECOG score: 0 to 2. At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to iRECIST criteria).
- Adequate organ function with. Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelets (Platelet, PLT) ≥ 100 × 109/L, Hemoglobin (HGB) ≥ 90 g/L.
- Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; serum albumin ≥30 g/L; after conventional hepatoprotective...
- Renal function: Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/mi (applying the standard Cockcroft-Gault formula).
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5 /PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, as long as PT and INR are within the range drawn up by...
- A predicted survival of ≥ 3 months. Female patients must be non-pregnant and non-lactating and are required to use a medically approved form of contraception (e.g., IUD, pill or condom) during study treatment and for at...
- Symptomatic brain metastases. A prior history of a primary tumor outside of the colorectal cancer in 3 years Active autoimmune disease or autoimmune disease with potential for recurrence such as, but not limited to...
- people with any severe and/or uncontrolled disease. including. Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood...
- Those with renal failure requiring hemodialysis or peritoneal dialysis. Those with a history of immunodeficiency, including HIV-positive or suffering from other acquired or congenital immunodeficiency diseases, or a...
- Research treatment related to. Patients who have undergone major organ transplantation Those who have undergone major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to the...
- Those with a history of severe allergy. Women who are pregnant or breastfeeding At risk for bleeding, or with coagulation disorders, or undergoing thrombolytic therapy Those with a history of psychotropic substance...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China, 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.