Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer

NCT06387368 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: HE-202303
• Study Type: interventional
• Target: 488
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer.

Conditions

Pancreatic Cancer Non-resectable

Keywords

Huaier Granules; Capecitabine; Unresectable Pancreatic Cancer; Efficacy and Safety

Outcome Measures

Primary Outcomes (1)

• Overall survival

  It is defined as the time from the day of patient randomization to death due to any reason.

  Start of treatment until 2-year follow-up

Secondary Outcomes (5)

• Objective response rate

  Start of treatment until 2-year follow-up

• Progression free survival

  Start of treatment until 2-year follow-up

• Conversion surgery rate

  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 received a combination of Huaier granules and capecitabine regimen.The subject takes Huaier granules orally, 10g once, three times a day; take capecitabine 1250mg/m\^2 orally , twice a day (2500mg/m\^2/d), day 1-14, once every 3 weeks.

Drug: Huaier Granule

Control group

ACTIVE COMPARATOR

The subjects received the capecitabine monotherapy regimen. The subjects take capecitabine orally, 1250mg/m\^2, twice a day (2500mg/m\^2/d), day for 1-14 days, once every 3 weeks.

Drug: Capecitabine

Interventions

Huaier Granule DRUG

Huaier Granules: Oral administration, 10g once, 3 times a day. Capecitabine: oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d), day 1-14, once every 3 weeks.

Also known as: Z20000109#NMPA Approval Number#

Huaier treatment group

Capecitabine DRUG

Oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d), day 1-14, once every 3 weeks.

Also known as: Standard chemotherapy

Control group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old, regardless of gender.
• Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunity, and other programs.
• The patient voluntarily choose chemotherapy, and the plan is to take capecitabine monotherapy orally.
• ECOG score 0-3 points.
• The patients voluntarily participate in and cooperates with all aspects of the research, including but not limited to cooperating with treatment and follow-up, cooperating with the researcher in data collection, not actively taking other treatments, and signing a written informed consent form.

You may not qualify if:

• Known to be allergic to the components of Huaier granules or to avoid or use Huaier granules with caution (Huaier group).
• Patients with difficulty swallowing, complete or incomplete gastrointestinal obstruction (excluding those who have undergone gastrointestinal stenting or diversion surgery due to tumor related gastrointestinal obstruction and have a normal diet, can be included in the study normally), active gastrointestinal bleeding, perforation, and other oral medication difficulties.
• After actively reducing jaundice (including but not limited to bile duct/gallbladder puncture external drainage, nasobiliary duct external drainage, biliary stent internal drainage, biliary intestinal anastomosis internal drainage, etc.), the levels of aspartate aminotransferase, alanine aminotransferase, or total bilirubin are still 2.5 times higher than the upper limit of normal values.
• 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).
• Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 29, 2024

Record last verified: 2024-04