Targeted treatment with tislelizumab and HAIC for advanced liver metastasis from colon cancer
Targeted Treatment Based on CtDNA Genotyping Combined with Tislelizumab and HAIC As Salvage Treatment for Advanced Colorectal Cancer Liver Metastasis Failed from Standard Systemic Treatment (SALVLIV Trial)
This study is testing a new combination treatment for patients with advanced colon cancer that has spread to the liver, to see if it works better for those who haven't had success with standard therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | cetuximab, tislelizumab, Avelumab, Fruquintinib, chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06199232 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a combination treatment involving hepatic arterial infusion chemotherapy (HAIC), targeted therapy, and the PD-1 inhibitor tislelizumab for patients with advanced colorectal cancer liver metastasis (CRCLM) who have failed standard systemic treatments. The approach is based on ctDNA genotyping to tailor the treatment regimen for individuals with microsatellite stable (MSS) CRCLM. The study aims to provide a personalized treatment strategy to improve outcomes for patients who have limited options after standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with unresectable liver metastasis from colorectal cancer who have failed first- and second-line systemic treatments.
Not a fit: Patients with resectable liver metastasis or those who have not yet undergone standard systemic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, individualized option for patients with advanced liver metastasis from colon cancer who have exhausted standard treatment options.
How similar studies have performed: Previous studies have shown promising results with HAIC and targeted therapies for similar conditions, suggesting potential for success in this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Peking Univerisity Cancer Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiaodong Wang, M.D.
- Email: xiaodongw75@yahoo.com
- Phone: 0086-18611586227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.