Actively Recruiting
Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
Led by Sir Run Run Shaw Hospital · Updated on 2025-06-27
70
Participants Needed
6
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 80 years old (including 18 and 80)
- Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma
- Locally advanced or metastatic pancreatic ductal adenocarcinoma as per 2024 CSCO Guidelines
- No prior systemic therapy for pancreatic cancer
- Presence of measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function including neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, creatinine <1.5×ULN or creatinine clearance ≥60 ml/min, albumin ≥30 g/L, total bilirubin <5×ULN, AST <2.5×ULN, ALT <2.5×ULN (≤5×ULN if liver metastasis present), INR or PT <1.5×ULN, APTT <1.5×ULN
- Negative serum pregnancy test within 7 days before first treatment for fertile women
- Willingness to use highly effective contraception from first treatment until 24 weeks after trial completion if fertile or partner is fertile
- No other serious underlying medical conditions
- Voluntary participation with signed informed consent (or guardian/witness as applicable)
You will not qualify if you...
- Neuroendocrine or pancreatic acinar carcinoma
- Moderate to severe ascites confirmed by ultrasound
- Untreated active central nervous system or meningeal metastases
- Previous systemic therapies for pancreatic cancer including targeted therapy, immunotherapy, chemotherapy, or modern Chinese medicine with anti-tumor effects
- Surgery within 4 weeks before first trial treatment or not fully recovered from surgery within 4 weeks
- Radiation therapy within 3 months before first dose or extensive bone marrow/large field irradiation within 4 weeks
- History of other cancers within past 2 years
- Major cardiovascular impairments within 12 months such as congestive heart failure above NYHA class II, unstable angina, recent myocardial infarction, stroke, or unstable arrhythmia; QTc interval >480 ms
- Bleeding or thrombotic diseases, coagulopathy, or current thrombolytic therapy
- Clinically significant bleeding from tumor or hemoptysis within 2 weeks before first dose
- History of uncontrolled epilepsy, CNS disease, psychiatric illness, or hypertension affecting consent or medication adherence
- Active autoimmune disease requiring systemic therapy within previous 2 years
- Other comorbidities contraindicating trial participation
- Severe allergic reactions to trial drug active ingredient
- Pregnant, lactating, or unwilling to avoid pregnancy during trial
- Any medical condition interfering with safety, efficacy assessment, or adherence
- Vulnerable groups including mental illness, cognitive impairment, critical illness, pregnancy (except elderly/illiterate)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Not Yet Recruiting
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
3
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
4
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410021
Not Yet Recruiting
5
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
6
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xiaolong Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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