Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cho… (NCT06849180) | Clinical Trial Compass
RecruitingNot Applicable
Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cholangiocarcinoma Based on Multimodal Data
China198 participantsStarted 2024-12-31
Plain-language summary
This study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with different subtypes, helping clinicians to screen the most beneficial groups of various treatment schemes, and providing new ideas for safe treatment of high-risk patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. age ≥18 years; diagnosis of CHC confirmed by histology or cytology;
✓. patients with unresectable or metastatic CHC diagnosed on the basis of unresectable CHC who have received prior local therapy, systemic therapy, or a combination of both and have at least one measurable lesion (RECIST v1.1);
✓. survival time ≥ 3 months;
✓. ECOG PS 0-2;
✓. Child-Pugh A/B.
Exclusion criteria
✕. pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.
✕. history of other malignant tumors within the past five years, unless these tumors have been completely treated and have been free of active disease for five years prior to the first dose and are at low risk of recurrence.
✕. fully treated carcinoma in situ with no evidence of disease.
✕. history of gastrointestinal bleeding or significant bleeding tendency (e.g., with known active ulcers, fecal occult blood, etc.) within the past six months that precludes inclusion in the study; gastroscopy is required if there is persistent fecal occult blood.
✕. substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.
✕. other conditions that the investigator deems unsuitable for inclusion in the study. Inadequate information, such as incomplete data from laboratory tests, missing or poor quality imaging data, no prognostic information, etc., that the investigator considers unsuitable for inclusion in the study.