Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected

Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected

Blood collection and multi-cancer early detection testing

Multi-cancer early detection test

Mingxin Pan

This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection

Guangzhou BR

Zhujiang Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

All Conditions

Proteinuria

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Lenvatinib

Sorafenib

Treatment period: oral administration, 10g each time, 3 times a day. Continuous medication until the end of the study, failure of treatment, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgement, patient would no longer benefit from the treatment.

If the treatment of hepatobiliary malignancies needs to be changed due to disease progression, whether to continue the medication or not should be determined by the researcher.

Huaier Granule

Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib. Continuous medication until disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first. Refer to drug instructions for specific usage.

VEGFR-TKIs

Lu Wang

Li Tan

This is a prospective, single-arm, single-center, exploratory study. The purpose of this study is to explore the effect of Huaier Granule on nephrotoxicity associated with anti-angiogenesis targeted therapy for advanced hepatobiliary malignancies.

China is a country with a high incidence of liver cancer, and the incidence of primary liver cancer ranks the fourth among malignant tumors in China. Hepatocellular carcinoma (HCC) is the main type of liver cancer, accounting for 75% to 85%. About 39.0%-53.6% of HCC patients were already advanced when first visit and had lost the opportunity to receive radical treatment. Currently, anti-angiogenesis targeted drugs are recommended for the first- or second-line treatment of advanced hepatocellular carcinoma. Biliary tract carcinoma are rare, accounting for about 3% of all digestive system malignancies. BTC are aggressive and were usually found in advanced stage, with a 5-year survival rate less than 5%. For advanced BTC, chemotherapy is the mainly systematic therapy recommended by current guidelines, targeted therapy and immunotherapy have shown efficacy in the exploration of the first-line and post-line of BTC. Anti-angiogenesis targeted drugs including lenvatinib are recommended for the first- or second-line treatment of advanced BTC.

Kidney injury is one of the common adverse reactions of anti-angiogenesis targeted drugs, among which proteinuria is one of the most common adverse reactions. Multiple key clinical studies have shown that the incidence of proteinuria associated with targeted therapy ranges from 10% to 51%, and the incidence of drug reduction or interruption due to proteinuria ranges from 0.9% to 17%.

Huaier is an extract from a medicinal fungus. The main effective component of Huai Qi Huang granule is Trametes Robiniophila Murr, which has been used in the treatment of chronic kidney disease for more than ten years. It was found that the effect of Huai Qi Huang granule alone or combined with RASI in the treatment of proteinuria was better than conventional treatment. The effective component of Huaier granule is also Trametes Robiniophila Murr, and its content is higher than that of Huai Qi Huang granule. Therefore, it is speculated that Huaier granule have a certain effect on anti-angiogenesis targeted therapy associated proteinuria in advanced hepatobiliary malignancies.

In this study, 1 research centers will participate. This study planned to enroll 53 participants. All the participants will be treated with Huaier granule. In this study, participants will be followed up for 24 weeks.

Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.

Effect of Huaier Granule on Nephrotoxicity Associated With Anti-angiogenesis Targeted Therapy for Advanced Hepatobiliary Malignancies: a Single-arm, Single-center, Exploratory Study.

Proportion of subjects with VEGFR-TKIs drug reduction after 8 weeks treatment of Huaier granule.

Proportion of subjects with VEGFR-TKIs drug reduction after 16 weeks treatment of Huaier granule.

Proportion of subjects with VEGFR-TKIs drug discontinuation after 8 weeks treatment of Huaier granule.

Proportion of subjects with VEGFR-TKIs drug discontinuation after 16 weeks treatment of Huaier granule.

Objective response rate: proportion of subjects who achieved complete remission (CR) or partial remission (PR) by primary tumor imaging evaluation.

Disease control rate: proportion of subjects who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) by primary tumor imaging evaluation.

Progression free survival: time from the date when the subject first received targeted therapy he was receiving at the time of enrollment to the first observation of tumor progression or death from any cause.

Proportion of subjects who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) after 8 weeks treatment of Huaier granule.

Perform a 24-hour urine collection for protein measurement, CR is defined as urine protein level≤0.3g/24h; PR is defined as urine protein level\>0.3g/24h and\<3.5g/24h, and decrease more than 30% from baseline; SD is defined as urine protein level \>0.3g/24h and\<3.5g/24h, and decrease less than or equal to 30% from baseline (or increase less than or equal to 20% from baseline); treatment failure is defined as at least two 24-hour urine protein tests show an increase of urine protein level of more than 20% from baseline or≥3.5 g/24h, or admission to renal replacement therapy or death.

Mean value of the difference between baseline 24h urine protein level and the 24h urine protein level after 8 weeks treatment of Huaier granule.

Decrease rate: percentage of the difference between baseline 24h urine protein level and the 24h urine protein level after 8 weeks treatment of Huaier granule in baseline 24h urine protein level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies	NCT04835675	Hepatobiliary M...	Multi-cancer ea...	40 Years - 75 Years	Zhujiang Hospital
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies	NCT04835675	Hepatobiliary M...	Multi-cancer ea...	40 Years - 75 Years	Zhujiang Hospital
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.	NCT05673824	Nephrotoxicity	Huaier Granule VEGFR-TKIs	18 Years -	Fudan University

Spots Global Cancer Trial Database for hepatobiliary malignancies