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

• Status: Recruiting
• Trial end date: 2027-01-23
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Treatments: Cetuximab; Immune Checkpoint Inhibitors; Tislelizumab

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.