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

Launched by PEKING UNIVERSITY · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced colon cancer that has spread to the liver and has not responded to standard treatments. The researchers want to see how effective and safe a combination of targeted therapy, a drug called tislelizumab, and a method called hepatic arterial infusion chemotherapy (HAIC) can be in treating this condition. They aim to create a personalized treatment plan based on genetic testing of the cancer.

To participate in this trial, individuals must be between the ages of 18 and 80, have been diagnosed with colorectal cancer, and have liver metastasis that cannot be surgically removed. They should have already tried at least two standard treatments that did not work. Participants will be monitored closely throughout the trial to assess their response to the treatment and any side effects. It’s important for potential participants to discuss their health status with their doctor to determine if they meet the eligibility criteria, as there are specific health conditions that may exclude someone from joining.

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Eligibility criteria

• Inclusion Criteria:
• • 1. 18-80 years old.
• • 2. Colorectal cancer confirmed by histopatology.
• • 3. The metastasis is mainly located in liver.
• • 4. Unresectable liver metastasis is confirmed by CT/MRI scan and multidisciplinary.
• • 5. Failed from standard first- and second-line systemic treatment.
• • 6. At least one measurable lesion according to modified Response Evaluation Criteria in Solid Tumors guidelines (mRECIST).
• • 7. Eastern Cooperative Oncology Group (ECOG) performance status \<2.
• • 8. Child-Pugh A or B (≤ 7).
• • 9. Expectant survival time ≥ 3 months.
• 10. Adequate organ function as follows:
• • 1. Hemoglobin ≥ 90 g/L;
• • 2. Absolute neutrophil count ≥ 1.5×10\^9/L;
• • 3. Blood platelet count ≥ 775×10\^9/L;
• • 4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 5 times of upper limit of normal (ULN);
• • 5. Total bilirubin ≤ 2 times of ULN;
• • 6. Serum creatinine ≤ 1.5 times of ULN;
• • 7. Albumin ≥ 30 g/L.
• • 11. Patients sign informed consent.
• Exclusion Criteria:
• • 1. Extensive extrahepatic metastasis (\>25% of tumor burden in liver).
• • 2. HER2 (3+) or HER2 amplification.
• • 3. MSI-H or dMMR.
• • 4. Allergic to contrast media.
• • 5. Pregnant or lactational.
• • 6. Allergic to oxaliplatin or cetuximab.
• • 7. Coinstantaneous a lot of malignant hydrothorax or ascites.
• • 8. History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation).
• • 9. Coinstantaneous infection and need anti-infection therapy.
• • 10. Coinstantaneous peripheral nervous system disorder.
• • 11. History of obvious mental disorder and central nervous system disorder.
• • 12. Concomitant malignancy within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
• • 13. Without legal capacity.
• • 14. Impact the study because of medical or ethical reasons.
• • 15. 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.
• • 16. Uncorrectable coagulation disorder.
• • 17. 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.
• • 18. History of myocardial infarction within 12 months, or Grade III/IV of heart function.
• • 19. Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease.
• • 20. Any other subjects that the investigator considers ineligible.