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Completed
NCT06199232
Targeted Treatment Plus Tislelizumab and HAIC for Advanced CRCLM Failed From Standard Systemic Treatment
Conditions: Liver Metastasis Colon Cancer, ctDNA Genotype, MSS, Failed From Standard Treatment
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 47
Sponsor: Peking University
Location: Peking Univerisity Cancer Hospital Beijing Beijing Municipality
Summary
Hepatic arterial infuison chemothearpy (HAIC), targeted therapy, and programmed death-1 (PD-1) inhibitors have been demonstrated to be effective for colorectal cancer liver metastasis (CRCLM). Thus, the investigators will conduct a prospective trial to explore the efficacy and safety of targeted treatment based on genotyping or ctDNA genotyping combined with tislelizumab and HAIC as salvage treatment for advanced CRCLM failed from standard systemic treatment, aiming to provide individualized optimized regimen for microsatellite stable (MSS) CRCLM in salvage treatment.
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 \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.
Source: ClinicalTrials.gov (NCT06199232). StuddyBuddy aggregates publicly available trial information.