A Randomized, Controlled, Open-Label, Phase II Clinical Study of High-Dose Vitamin C Combined with Sindilizumab and Bevacizumab in BCLC Stage C Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500101730

Enrollment

Unknown

Registered

2025-04-29

Start date

2025-04-30

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cancer

Interventions

test group:High-dose vitamins in combination with target-immunotherapy regimen (combination regimen): antitumor therapy using high-dose vitamins in combination with sindilizumab in combination with be

Control group:Target-immunotherapy regimen (standard regimen): application of sindilizumab in combination with bevacizumab for antitumor therapy.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old, gender is not limited; 2. patients with advanced hepatocellular carcinoma diagnosed as hepatocellular carcinoma by diagnostic criteria, BCLC stage C, and the tumor is not resectable; 3. The preoperative liver function evaluation of Child-Pugh grade A or B, able to tolerate targeted immunotherapy; 4. Patients with good cardiorespiratory function who can tolerate surgery; 5. Patients who can understand the situation of this study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. localized treatment (including radiofrequency ablation, external radiation therapy) has been performed before enrollment; 2. Tumor has undergone distant metastasis, e.g., metastasis to lungs, brain, bones, etc; 3. Contraindications to high-dose vitamin C treatment (G-6-PD deficiency and vitamin C allergy). 4. severe varices of esophagogastric fundus vein, tendency to gastrointestinal bleeding, or previous gastrointestinal hemorrhage 5. pathology suggesting intrahepatic cholangiocellular carcinoma and mixed cell carcinoma and other non-hepatocellular carcinomas 6. Combination of serious hematologic, renal, respiratory, digestive and neurological diseases, etc. 7. other conditions that the investigator considers unsuitable for participation in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;Overall survival;	—

Secondary

Measure	Time frame
adverse reaction rate;	—

Countries

China

Contacts

Public ContactWeixing Guo

the Third Affiliated Hospital of Naval Medical University(Eastern Hepatobiliary Surgery Hospital)

weixingg88@126.com+86 139 1858 9919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026