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

NCT06368063 | Recruiting Phase 4 DMC

• 1 other identifier: HE-202301
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer Resectable

Keywords

Huaier granule; Postoperative adjuvant therapy; Resectable pancreatic cancer; Efficacy and safety

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  It is defined as the time from the first day after radical resection of pancreatic cancer to recurrence or all-cause death of pancreatic cancer.

  Start of treatment until 2-year follow-up

Secondary Outcomes (4)

• Overall survival

  Start of treatment until 2-year follow-up

• Progression-free survival

  Start of treatment until 2-year follow-up

• The incidence and severity of adverse events (AE) and severe adverse events (SAE)

  Start of treatment until 2-year follow-up

• The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)

  Start of treatment until 2-year follow-up

Study Arms (2)

Huaier treatment group

EXPERIMENTAL

The subjects take Huaier granules orally and start taking them within 15-30 days after surgery until the end of the study, intolerable toxicity occurs, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.

Drug: Huaier granule

Standard chemotherapy group

ACTIVE COMPARATOR

Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment) * Gemcitabine combine with capecitabine * mFOLFIRINOX solution * Gemcitabine monotherapy * Tegafur，gimeracil and oteracil potassium capsules monotherapy

Drug: chemotherapy drugs

Interventions

Huaier granule DRUG

Huaier Granules: Oral administration, 10g once, 3 times a day, starting from 15-30 days after surgery until the end of the study, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.

Also known as: Z20000109#NMPA Approval Number#

Huaier treatment group

chemotherapy drugs DRUG

Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment) · Gemcitabine combine with capecitabine Gemcitabine 1000mg/m\^2 intravenous infusion for more than 30 minutes, day 1, 8, 15,repeat every 4 weeks for a total of 6 cycles. · mFOLFIRINOX solution Oxaliplatin 85mg/m\^2 intravenous infusion for 2 hours, day 1 Ilitacan 150mg/m\^2 intravenous infusion for more than 30-90 minutes, day 1 Leucovorin calcium 400mg/m\^2 intravenous infusion for 2 hours, day 1 5-FU 2400mg/m\^2, continuous intravenous infusion for 46 hours, repeated every 2 weeks, administered until 24 weeks. * Gemcitabine monotherapy 1000mg/m\^2 intravenous infusion, day 1 qw x 7, rest for 1 week Afterwards, qw × 3, take a week off, and administer medication for 6 months. * Tegio capsules monotherapy Take tegio capsules orally, 80mg/d, day 1-28, repeated every 6 weeks, administered until 6 months.

Also known as: Standard chemotherapy

Standard chemotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xi'an Jiaotong University: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Zheng Wang

Xi'an, Shannxi, 710065, China

RECRUITING

MeSH Terms

Interventions

Antineoplastic Agents

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zheng Wang, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Wang, PhD

CONTACT

+8615902993665; zheng.wang11@mail.xjtu.edu.cn

Liang Han, PhD

CONTACT

+8613379181359; hanliangxjtu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: May 6, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CN (1)