RecruitingPhase 2

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

China70 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 18-80 years old (including the cutoff value).
✓. patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) disease from multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (group lead unit).
✓. locally advanced or metastatic PDAC according to the 2024 CSCO Guidelines for the Management of Pancreatic Cancer.
✓. no prior systemic therapy.
✓. presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
✓. Eastern Cooperative Oncology Group PS 0 or 1.
✓. have a life expectancy of at least 3 months.
✓. adequate organ function (absolute neutrophil count ≥1.5×109/L; Platelet count ≥100×109/L; Creatinine \<1.5×ULN (upper limit of normal) or creatinine clearance (CRCI) ≥60 ml/min; Albumin ≥30g/L; Total bilirubin \<5×ULN; Aspartate aminotransferase (AST) \<2.5×ULN; Alanine aminotransferase (ALT) \<2.5×ULN (≤5×ULN is acceptable if liver metastasis is present); INR or PT \< 1.5×ULN, APTT \< 1.5×ULN.

Exclusion criteria

What they're measuring

ORR

Timeframe: 2 years

Trial details

NCT IDNCT06825546

SponsorSir Run Run Shaw Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Xiaolong Liu

13588457667 liuxiaolong@zju.edu.cn

View on ClinicalTrials.gov More Advanced Pancreatic Ductal Adenocarcinoma trials