Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSir Run Run Shaw Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
neuroendocrine (carcinoid, islet cell) or pancreatic acinar carcinoma.
Patients had moderate to severe ascites (ascites was defined by B-ultrasound).
untreated active central nervous system or meningeal metastases.
Previous systemic therapies such as targeted therapy, immunotherapy, chemotherapy, and modern Chinese medicine with anti-tumor indications or other treatments such as surgery and particle implantation have been used to treat pancreatic cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
Icaritin
DrugIcaritin 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.
AG chemotherapy
DrugGemcitabine (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
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Icaritin + AG chemotherapyExperimental treatment 2 interventions
Group B: AG chemotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ORR
The proportion of patients with optimal response achieving complete or partial response
Time frame
2 yearsSecondary outcomes
1
PFS
If the patient has not progressed or died at the last follow-up, the date on which the clinician last confirmed that there was no tumor progression will prevail. For patients who are lost to follow-up, the date when the tumor was last recorded as not progressing will be considered. Patients who have started a new treatment prior to progression will have the date their tumor was last recorded prior to the new treatment.
Time frame
2 years2
OS
If the patient is still alive at the last follow-up, the date of the clinician's last confirmation of the patient's survival shall prevail. For patients who were lost to follow-up, the date of last recorded patient survival was considered.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov