Exploring new treatment strategies for patients with unresectable combined liver cancer

Novel Subtypes and Treatment Strategies of Patients with Unresectable Mixed Hepatocellular Cholangiocarcinoma Based on Multimodal Data

This study is trying to find new treatment options for adults with a type of liver cancer that can't be surgically removed by using advanced technology to better understand their specific cancer subtypes.

Quick facts

• Study type: Observational
• Enrollment: 198 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongda Hospital (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06849180 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify novel treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma (CHC) by classifying patients into subtypes using artificial intelligence and multi-omics data. It will collect comprehensive data, including genomics, proteomics, and clinical records, from adult patients diagnosed with unresectable CHC. The study will utilize advanced data integration techniques to develop a large model for diagnosis and treatment recommendations, ultimately helping clinicians tailor therapies to specific patient subtypes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed unresectable combined hepatocellular-cholangiocarcinoma who have received prior therapies.

Not a fit: Patients with a history of other malignancies within the past five years or those with significant bleeding tendencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with unresectable combined liver cancer.

How similar studies have performed: While similar approaches using multi-omics and AI in cancer treatment have shown promise, this specific study represents a novel application in the context of unresectable combined hepatocellular-cholangiocarcinoma.

Eligibility criteria

Inclusion Criteria:

1. age ≥18 years; diagnosis of CHC confirmed by histology or cytology;
2. 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);
3. survival time ≥ 3 months;
4. ECOG PS 0-2;
5. Child-Pugh A/B.

Exclusion Criteria:

1. pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.
2. 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.
3. fully treated carcinoma in situ with no evidence of disease.
4. 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.
5. substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.
6. 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.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Gao-Jun Teng, M.D — Zhongda hospital, Southeast university, Nanjing, China
• Study coordinator: Gao-Jun Teng, M.D

Conditions: Combined Hepatocellular-cholangiocarcinoma, Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma, CHC, cHCC-ICC