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NCT06368063RecruitingPhase 4

The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer

Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer

Source: ClinicalTrials.gov · Last updated 8 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
642 (estimated)
First submitted
11 Apr 2024
Start date
May 2024
Primary completion date
Mar 2026
Lead sponsor
Xi'an Jiaotong University
NCT number
NCT06368063

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 642
  • From May 2024 to the primary completion date, Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment;
  • Concomitant severe infection;
  • 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).

Other illness

  • 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;

Other

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zheng Wang
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.