Effect and Safety of Huaier Granules Combined With Targeted Drugs and Anti- PD-(L)1 Antibody on the Treatment of uHCC

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multi-center, exploratory 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 on the first-line treatment of unresectable hepatocellular carcinoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Huazhong University of Science and Technology; LinkDoc Technology (Beijing) Co. Ltd.
• Treatments: Apatinib; Atezolizumab; Bevacizumab

Criteria

Inclusion Criteria:

1. 18 years and older

2. Diagnosed as unresectable hepatocellular carcinoma (CNLC liver cancer stage II and III, did not meet the indications of transcatheter arterial chemoembolization or disease progression after transcatheter arterial chemoembolization) by histopathological and/or cytological examination, or meeting the clinical diagnostic criteria of primary liver cancer by [The Standard for Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition)].

3. Liver function status Child-Pugh Class A or B, 7 points.

4. Planned to receive one of the following treatment regimen: Atezolizumab and Bevacizumab, Camrelizumab and Apatinib, Sintilimab and Bevacizumab.

5. HCC patients treated with TACE can be enrolled only if tumor progression after TACE or 3 months after TACE.

6. Patients with active HBV infection can be enrolled if meeting one of the following conditions: ① within 28 days before enrollment, the patient's HBV DNA is < 500 IU / ml, if they have received anti HBV treatment, they need to continue the original antiviral treatment; if not, they need to receive anti-HBV treatment throughout the medication (according to local treatment standards; e.g. entecavir); ② for those with HBV DNA > 500 IU / ml and without antiviral treatment, they shall receive anti-HBV treatment for at least 7 days before joining the study (according to local treatment standards; e.g. entecavir), and are willing to continue to receive anti-HBV treatment during the study. Before joining the study, the serum HBV-DNA virus shall be retested and decreased by more than 1 log value; ③ For those with HBV DNA > 500 IU / ml and who have received antiviral treatment, they shall receive anti-HBV treatment for at least 7 days before enrollment (according to local treatment standards; e.g. entecavir), and are willing to continue to receive anti-HBV treatment during the study. Before enrollment, the serum HBV-DNA virus level shall be retested and decreased;

7. Patients with active HCV infection can be enrolled when disease were stable after treatment;

8. Agree to receive Huaier granule treatment after enrollment.

9. At least one evaluable tumor lesion.

10. Be conscious, have language expression ability or reading ability, can communicate normally, and cooperate to complete the questionnaire evaluation;

11. Volunteer to join the study and sign the informed consent form.

Exclusion Criteria:

1. More than two active primary tumors at the same time.

2. Portal vein tumor thrombus invaded the superior mesenteric vein.

3. Patients received systemic therapy, radiotherapy or transcatheter arterial chemoembolization in the past 3 months.

4. Patients allergic to the components of Huaier granules, or avoid to use Huaier granules or use with caution.

5. Patients not able to take medication orally.

6. Pregnant or lactating women or women prepare for pregnancy.

7. Coagulation dysfunction (INR > 2.0, PT> 16s) or diseases with high possibility of bleeding (including but not limited to esophageal and/or gastric variceal bleeding, active ulcer, uncontrolled hypertension).

8. Participating in clinical trials of other drugs.

9. Refused to cooperate with follow-up.

10. Other reasons that the researcher considers unsuitable to participate in this study.