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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Univerisity Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaodong Wang, M.D.
xiaodongw75@yahoo.com
0086-18611586227
Time Frame
Start Date: 2024-01-23
Estimated Completion Date: 2027-01-23
Participants
Target number of participants: 47
Treatments
Experimental: Treatment Arm
HAIC combined with targeted therapy and PD-1 inhibitor
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov

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