NCT06199232Completed
Targeted Treatment Plus Tislelizumab and HAIC for Advanced CRCLM Failed From Standard Systemic Treatment
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)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 24 Dec 2023
- Start date
- 23 Jan 2024
- Primary completion date
- 10 Jul 2026
- Lead sponsor
- Peking University
- Diseases
- Colorectal cancer
- NCT number
- NCT06199232
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 23 Jan 2024 to the primary completion date, 10 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant malignancy within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
Other illness
- Allergic to contrast media.
- 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.
- 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.
Other
- Extensive extrahepatic metastasis (\>25% of tumor burden in liver).
- HER2 (3+) or HER2 amplification.
- MSI-H or dMMR.
- Pregnant or lactational.
- Without legal capacity.
- Impact the study because of medical or ethical reasons.
- Any other subjects that the investigator considers ineligible.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Univerisity Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.