BridgeMD
New treatment option for Advanced Pancreatic Ductal Adenocarcinoma
Official title Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma
ClinicalTrials.gov ID: NCT06825546
What this study is testing
What is Icaritin?
Icaritin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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...
- surgery for any reason (other than diagnostic biopsy), within 4 weeks after the first trial treatment, and/or the subject did not fully recover from...
- history of RT within 3 months of the first dose of trial treatment. No more than 30% bone marrow irradiation or large field irradiation should be...
See the full eligibility 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...
- in a fertile woman, a negative serum pregnancy test within 7 days before the first trial treatment;
- willingness to use a highly effective contraceptive method (failure rate \< 1.0% per year) from the first study treatment until 24 weeks after completion of the trial treatment, if the woman is fertile or the male...
- no other serious underlying medical conditions.
- voluntarily participated in this study and signed informed consent. If the people were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them...
- 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...
- surgery for any reason (other than diagnostic biopsy), within 4 weeks after the first trial treatment, and/or the subject did not fully recover from surgery within 4 weeks after the first trial treatment.
- history of RT within 3 months of the first dose of trial treatment. No more than 30% bone marrow irradiation or large field irradiation should be used in the 4 weeks before the first trial treatment.
- patients with a history of other cancers within the past 2 years.
- major cardiovascular impairment in the 12 months before the first dose of study drug: such as a history of congestive heart failure higher than NYHA class II, unstable angina, myocardial infarction, or stroke due to...
- with bleeding or thrombotic diseases or receiving thrombolytic therapy, and coagulopathy; Patients who were deemed by the investigator to be ineligible for participation in the study.
- clinically significant hemoptysis or tumor bleeding of any cause within 2 weeks before the first dose of study intervention.
- patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric illness, or hypertension The investigator will determine whether clinical severity prevents informed consent from being...
- had active autoimmune disease requiring systemic therapy within the previous 2 years.
- may have other comorbidities that are relatively contraindicated in this trial.
- had a severe allergic reaction to the active ingredient of the trial drug.
- were pregnant or lactating, or were unwilling to plan pregnancy during the trial.
- any other medical condition that the investigator considered to interfere with the requirements of the trial in terms of safety or how well it works assessment or adherence to treatment.
- vulnerable groups except the elderly/illiterate, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China; Hangzhou, Zhejiang, China; Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.