Pancreatic cancer
Conditions
Interventions
Chemotherapy group:Receiving any standard first-line chemotherapy regimen that includes gemcitabine (GEM) for advanced pancreatic cancer.
Combination group:Receiving any standard first-line chemotherapy regimen that includes gemcitabine (GEM) for advanced pancreatic cancer, combined with a modified version of Wenpi Sanjie Decoction. The
Sponsors
Dongfang Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients who meet both the Chinese and Western medicine diagnostic criteria for pancreatic cancer; (2) Patients who meet the Western medicine diagnostic criteria for pancreatic cancer and are classified as stage III–IV according to the TNM staging system for pancreatic cancer; (3) Patients who meet the chemotherapy indications specified in the clinical guidelines; (4) Patients with a Karnofsky Performance Status (KPS) score = 60 and an expected survival of more than 3 months; (5) Patients aged 18–75 years (inclusive of both endpoints), regardless of gender; (6) Patients with complete medical records, good compliance of both the patient and their family members, the ability to understand the study protocol, signed informed consent, and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients with severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, severe infectious diseases, shock, coma, cachexia, or other critical conditions indicating poor general health; (2) Patients with concurrent malignant tumors in other organs; (3) Patients allergic to chemotherapeutic agents or any components of the Chinese herbal decoction; (4) Women who are pregnant or breastfeeding; (5) Patients who have participated in other clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response evaluation for solid tumors;Traditional Chinese Medicine (TCM) syndrome score;Tumor markers;Pain score;Karnofsky Performance Status (KPS) score;Eastern Cooperative Oncology Group (ECOG) performance status score;Pancreatic cancer-specific quality of life score;Cancer-related fatigue score;Gastrointestinal quality of life score;Body weight;Immune function assessment; | — |
Countries
China
Contacts
Public ContactLi Quanwang
Dongfang Hospital, Beijing University of Chinese Medicine
Outcome results
None listed