A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Age: 18 years old and above but 75 years old and below, regardless of gender; 2. Previously received at least two standard chemotherapy regimens for advanced colorectal cancer and demonstrated disease progression or intolerance to the last regimen. Patients who have received adjuvant/neoadjuvant chemotherapy and experience recurrence during or within 6 months after completion of adjuvant/neoadjuvant chemotherapy can be considered as a chemotherapy regimen for advanced disease; 3. There are sufficient tissue specimens that have been tested as pMMR (immunohistochemistry) or MSS (PCR or NGS) 4. Have at least one measurable lesion (RECIST v1.1); 5. ECOG PS score is 0 or 1; 6. Expected survival exceeds 3 months; 7. The main organ functions are normal, which meets the following criteria: Absolute neutrophil count ≥ 1.5 x 10 \^ 9/L Hemoglobin ≥ 9 g/dL Platelet count ≥ 100 x 10 \^ 9/L Creatinine clearance rate ≥ 50 mL/min, evaluated using the Cockcroft\&Gault fo…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source