Status:
RECRUITING
Targeted Treatment Plus Tislelizumab and HAIC for Advanced CRCLM Failed from Standard Systemic Treatment
Lead Sponsor:
Peking University
Conditions:
Liver Metastasis Colon Cancer
CtDNA Genotype
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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, t...
Detailed Description
Although surgery has been demonstrated to improve the prognosis of patients with colorectal cancer liver metastasis (CRCLM), only 20% of patients with CRCLM is candidate for surger. Irinotecan-/oxalip...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Extensive extrahepatic metastasis (\>25% of tumor burden in liver).
- HER2 (3+) or HER2 amplification.
- MSI-H or dMMR.
- Allergic to contrast media.
- Pregnant or lactational.
- 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.
- Concomitant malignancy within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
- Without legal capacity.
- Impact the study because of medical or ethical reasons.
- 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.
- Any other subjects that the investigator considers ineligible.
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 23 2027
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06199232
Start Date
January 23 2024
End Date
January 23 2027
Last Update
December 4 2024
Active Locations (1)
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1
Peking Univerisity Cancer Hospital
Beijing, Beijing Municipality, China, 100142