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Huaier granules combined with targeted drug and anti- PD-(L)1 antibody.

There are there specific regimens:

Huaier granules combined with Atezolizumab and Bevacizumab, Huaier granules combined with Camrelizumab and Apatinib, Huaier granules combined with Sintilimab and Bevacizumab.

Targeted drug combined with anti-PD-(L)1 antibody.

There are there specific regimens:

Atezolizumab combined with Bevacizumab, Camrelizumab combined with Apatinib, Sintilimab combined with Bevacizumab.

Treatment period: Huaier Granule, oral administration, 10g each time, 3 times a day. Continuous medication until the end of the study, 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. After disease progression, whether to continue the medication or not should be determined by the researcher and patient together.

Huaier granule

Targeted Drug and Anti-PD-(L)1 antibody: 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.

Atezolizumab + Bevacizumab

Camrelizumab+Apatinib

Sintilimab+Bevacizumab

Jia Fan, PhD

Huichuan Sun, PhD

This is a prospective, multi-center, controlled study. The purpose of this study is to evaluate the efficacy, safety and the impact on the quality of life of Huaier Granules combined with targeted drugs and anti-PD-(L)1 antibody compared with targeted drugs combined with anti-PD-(L)1 antibody in first line treatment of unresectable hepatocellular carcinoma.

China is a country with a high incidence of liver cancer. The latest forecast data of the International Agency for Research on Cancer (IARC) shows that the number of newly diagnosed liver cancer in China in 2020 is close to half of the total in the world. Hepatocellular carcinoma (HCC) is the main type of liver cancer, accounting for more than 85%-90%. About 60% of HCC patients are of advanced stage when first visit, and lose the opportunity to receive radical treatment. Currently, targeted drugs are recommended by the guidelines for first-line treatment of advanced HCC. Several studies have shown that the use of immune checkpoint inhibitors (mainly PD-(L)1 inhibitors) combined with targeted drugs can increase the survival benefits of patients with advanced HCC. However, the overall ORR of first-line treatment is less than 50%, and some patients have experienced high-grade adverse events.

Huaier granules is an extract from a medicinal fungus. Previous studies have shown that Huaier granules can inhibit the proliferation, angiogenesis, metastasis and invasion of cancer cells, and can reverse the resistance of targeted drugs. Huaier granules is one of the most commonly used Chinese patent medicines in the treatment of HCC, and is recommended by CSCO guidelines（liver cancer）. Several previous studies have shown that Huaier granules can improve the efficacy and reduce the incidence of adverse events in all stages of HCC treatment.

In this study, about 10 research centers will participate. The study will enroll 600 participants. The experimental group will enroll 200 participants who will be treated with Huaier granules combined with targeted drug and anti- PD-(L)1 antibody, the three specific treatment regimens were Huaier granules combined with Atezolizumab and Bevacizumab, Huaier granules combined with Camrelizumab and Apatinib, Huaier granules combined with Sintilimab and Bevacizumab. The control group will enroll 400 participants who will be treated with targeted drug combined with anti-PD-(L)1 antibody, the three specific treatment regimens were Atezolizumab combined with Bevacizumab, Camrelizumab combined with Apatinib, Sintilimab combined with Bevacizumab. In this study, participants will be followed up for 12 months.

Effect and Safety of Huaier Granules Combined With Targeted Drugs and Anti-PD-(L)1 Antibody Compared With Targeted Drugs Combined With Anti-PD-(L)1 Antibody in First Line Treatment of Unresectable Hepatocellular Carcinoma(uHCC)

Effect and Safety of Huaier Granules Combined With Targeted Drugs and Anti-PD-(L)1 Antibody Compared With Targeted Drugs Combined With Anti-PD-(L)1 Antibody in First Line Treatment of Unresectable Hepatocellular Carcinoma: a Prospective, Multi-center Study

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

Progression free survival: time from the date when the subject first received Huaier Granules combined with targeted drug and anti-PD-(L)1 antibody to the first observation of tumor progression or death from any cause.

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

Time to response: time from the date when the subject first received Huaier Granules combined with targeted drug and anti-PD-(L)1 antibody to the first observation of tumor remission (CR or PR)

Duration of response: time from the first observation of tumor remission (CR or PR) to the first observation of tumor progression or death from any cause after the subject was treated with Huaier Granule combined with targeted drug and anti-PD-(L)1 antibody.

Evaluated by the quality of life core scale \[The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30(EORTC QLQ-C30 )(Chinese version)\] developed by European cancer research and treatment organization. The scope of each domain is 0 to 100. Higher scores in the functional and general health areas indicate better functional status and quality of life, and higher scores in the symptomatic areas indicate more symptoms or problems (poorer quality of life).

Adverse events of special interest: proteinuria, enteritis, autoimmune myocarditis.

Spots Global Cancer Trial Database for sintilimab+bevacizumab