NCT06825546

Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma

A Multicenter Study Assessing the Efficacy and Safety of Icaritin in Combination With AG Chemotherapy Versus AG Chemotherapy Alone in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus,we investigated the efficacy and safety of Icaritin administered in conjunction with AG in patients newly diagnosed with advanced pancreatic ductal adenocarcinoma, compare with AG only.

Detailed description

This study aims to evaluate the superiority of Icaritin soft capsules combined with the AG chemotherapy regimen (including gemcitabine) compared to the AG regimen alone. By modulating the immune microenvironment, the combined therapy is expected to provide synergistic enhancement. This will lay the groundwork and provide data for subsequent large-scale randomized controlled clinical trials, ultimately offering more effective combination therapies for patients with advanced pancreatic cancer and improving survival outcomes.

Conditions

• Advanced Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Icaritin	Icaritin soft capsules, 600 mg, taken twice daily, should be swallowed with warm water within 30 minutes after breakfast and dinner. If a patient misses a dose and cannot take it within 2 hours after a meal, they should continue with the next scheduled dose without needing to make up for the missed dose. Gemcitabine, 1000 mg/m², is administered on days 1 and 8, followed by a 14-day pause, constituting a 21-day treatment cycle. Nab-paclitaxel, 125 mg/m², is also administered on days 1 and 8, with a 14-day pause, making up a 21-day treatment cycle.
DRUG	AG chemotherapy	Gemcitabine (1000 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush. Nab-paclitaxel (125 mg/m²) + saline (100 mL), infused intravenously over 30 minutes, followed by a 100 mL saline flush

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-01
• Completion: 2027-10-01
• First posted: 2025-02-13
• Last updated: 2025-06-27

Locations

6 sites across 1 country: China