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

Official title

Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study on the Efficacy and Safety of Huaier Granules Combined With Capecitabine Versus Capecitabine Alone in the Treatment of Unresectable Pancreatic Cancer

Overview

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.

Detailed description

This study is a prospective, multicenter, randomized, open label, parallel controlled clinical study. It is expected to include approximately 488 patients diagnosed with unresectable pancreatic adenocarcinoma by tissue or cellular pathology who visited the selected research center from April 2024 to March 2026. The treatment regimen will be capecitabine monotherapy orally. Among them, the Huaier group uses "capecitabine+Huaier granules", and is expected to include 244 cases; The control group received capecitabine and is expected to include 244 cases.

Interventions

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

Primary outcome measures

• Overall survival [Time frame: Start of treatment until 2-year follow-up]

Secondary outcome measures (5)

• Objective response rate [Time frame: Start of treatment until 2-year follow-up]
• Progression free survival [Time frame: Start of treatment until 2-year follow-up]
• Conversion surgery rate [Time frame: Start of treatment until 2-year follow-up]
• The incidence and severity of adverse events (AE) and severe adverse events (SAE) [Time frame: 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) [Time frame: Start of treatment until 2-year follow-up]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years old, regardless of gender.
• The patient has a clear evaluable lesion (RECIST 1.1) and is diagnosed with pancreatic adenocarcinoma through tissue or cellular pathology. Clinical evaluation suggests that radical surgical resection cannot be performed (due to jaundice and gastrointestinal obstruction caused by tumor compression, stent treatment or normal inclusion of biliary and gastrointestinal anastomosis can be performed).
• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06387368 · HE-202303

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗