NCT06368063 The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
| NCT ID | NCT06368063 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Xi'an Jiaotong University |
| Condition | Pancreatic Cancer Resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 642 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 642 participants in total. It began in 2024-05-06 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer
Eligibility Criteria
Inclusion Criteria: * Age range from 18 to 80 years old, regardless of gender; * Pancreatic cancer was diagnosed by histopathology after radical surgery within 12 weeks before enrollment; * Did not receive neoadjuvant therapy before surgery and did not receive any adjuvant therapy after surgery; * ECOG score 0-3 points; * Those who choose to use standard chemotherapy independently based on their own situation, or choose Huaier granules for subsequent treatment, voluntarily participate in and cooperate with various research work, including but not limited to cooperating with treatment and follow-up, cooperating with researchers for data collection, and not actively taking other treatments. * The subjects voluntarily signed a written informed consent form before participating in this study. Exclusion Criteria: * Known to be allergic to the components of Huaier granules or to avoid or use Huai er granules with caution (Huaier group); * Difficulties in taking oral medication due to active gastrointestinal bleeding, perforation, gastric paralysis, etc; * Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study. * History of merging with other malignant tumors; * Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment; * Concomitant severe infection; * Child Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate\<90ml/min); * Pregnant or lactating women or those planning to conceive; * The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).
Contact & Investigator
Zheng Wang, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital Xi'an Jiaotong University
Frequently Asked Questions
Who can join the NCT06368063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatic Cancer Resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06368063 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06368063 currently recruiting?
Yes, NCT06368063 is actively recruiting participants. Contact the research team at zheng.wang11@mail.xjtu.edu.cn for enrollment information.
Where is the NCT06368063 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06368063 clinical trial?
NCT06368063 is sponsored by Xi'an Jiaotong University. The principal investigator is Zheng Wang, PhD at First Affiliated Hospital Xi'an Jiaotong University. The trial plans to enroll 642 participants.
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