Targeted Treatment Plus Tislelizumab and HAIC for Advanced CRCLM Failed From Standard Systemic Treatment

Korábbi kezelés

• Concomitant malignancy within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.

Más betegség

• Allergic to contrast media.
• Allergic to oxaliplatin or cetuximab.
• Coinstantaneous a lot of malignant hydrothorax or ascites.
• History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation).
• Coinstantaneous infection and need anti-infection therapy.
• Coinstantaneous peripheral nervous system disorder.
• History of obvious mental disorder and central nervous system disorder.
• Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment.
• Uncorrectable coagulation disorder.
• Obvious abnormal in ECG or obvious clinical symptoms of heart disease, like congestive heart failure, coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
• History of myocardial infarction within 12 months, or Grade III/IV of heart function.
• Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease.

Egyéb

• Extensive extrahepatic metastasis (\>25% of tumor burden in liver).
• HER2 (3+) or HER2 amplification.
• MSI-H or dMMR.
• Pregnant or lactational.
• Without legal capacity.
• Impact the study because of medical or ethical reasons.
• Any other subjects that the investigator considers ineligible.

• 18-80 years old.
• Colorectal cancer confirmed by histopatology.
• The metastasis is mainly located in liver.
• Unresectable liver metastasis is confirmed by CT/MRI scan and multidisciplinary.
• Failed from standard first- and second-line systemic treatment.
• At least one measurable lesion according to modified Response Evaluation Criteria in Solid Tumors guidelines (mRECIST).
• Eastern Cooperative Oncology Group (ECOG) performance status \<2.
• Child-Pugh A or B (≤ 7).
• Expectant survival time ≥ 3 months.
• Adequate organ function as follows:
  • Hemoglobin ≥ 90 g/L;
  • Absolute neutrophil count ≥ 1.5×10\^9/L;
  • Blood platelet count ≥ 775×10\^9/L;
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 5 times of upper limit of normal (ULN);
  • Total bilirubin ≤ 2 times of ULN;
  • Serum creatinine ≤ 1.5 times of ULN;
  • Albumin ≥ 30 g/L.
• Patients sign informed consent.