NCT06387368

Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer

Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 488 (estimated)
• Sponsor: Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.

Detailed description

This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.

Conditions

• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
DRUG	Huaier Granule	Huaier Granules: Oral administration, 10g once, 3 times a day. Capecitabine: oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d), day 1-14, once every 3 weeks.
DRUG	Capecitabine	Oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d), day 1-14, once every 3 weeks.

Timeline

• Start date: 2024-05-01
• Primary completion: 2028-03-01
• Completion: 2028-08-01
• First posted: 2024-04-29
• Last updated: 2024-04-29