Statin Addition to Chemotherapy for Advanced Pancreatic Cancer

NCT06241352 | Completed Phase 2 DMC

• 1 other identifier: ChanghaiH-PP13
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The results of previous studies conducted by our team have revealed that the use of statins can more effectively hinder the growth of drug-resistant pancreatic cancer cells. The primary objective of this study was to investigate the role of statins in treating pancreatic cancer by assessing the safety and therapeutic impact of combining chemotherapy with statins in patients with advanced pancreatic cancer.

Conditions

Advanced Pancreatic Cancer

Keywords

advanced pancreatic cancer; statin; chemotherapy resistance

Outcome Measures

Primary Outcomes (1)

• Decrease rate of CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125)

  The proportion of patients with a decrease of over 20% in CA19-9 (with CA19-9 negative patients referenced against CEA or CA-125) one month after the start of treatment.

  1-2 month

Secondary Outcomes (3)

• Event-free Survival

  1 year

• Overall survival

  2 years

• Disease control rate

  6 months

Study Arms (1)

Statin addition to chemotherapy

EXPERIMENTAL

Chemotherapy plus atorvastatin was used in locally advanced pancreatic cancer.

Drug: statin addition to chemotherapy

Interventions

statin addition to chemotherapy DRUG

Chemotherapy was administered along with 80mg of atorvastatin per day. Atorvastatin was discontinued when CA19-9 levels (with CA19-9 negative patients referenced against CEA or CA-125) rose more than 20% above baseline.

Statin addition to chemotherapy

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≥18 years old and ≤80 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
• Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
• Imaging studies confirmed the diagnosis of locally advanced or metastatic pancreatic cancer patients.
• The patients were in the plateau stage after chemotherapy, as indicated by the CA19-9 values (with CA19-9 negative patients referenced against CEA or CA-125) fluctuating by less than 20% over an interval of more than 3 weeks.
• Life expectancy of greater than 90 days, as judged by the investigator.
• Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/ mm3.
• Normal liver function: serum total bilirubin≤2.0mg/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 times of the upper limit of normal value.
• Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min.
• No severe comorbidities.

You may not qualify if:

• Patients with poor condition can not tolerate chemotherapy.
• Patients who have previously taken lipid-lowering drugs (such as statins, fibrates, ezetimibe, or PCSK9 inhibitors).
• Patients who are taking warfarin, verapamil, clopidogrel, digoxin, amiodarone, etc.
• Impaired organ functions: heart failure (New York Heart Association III- IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
• Patients diagnosed with other cancer within 5 years.
• Patients who are pregnant or breastfeeding.
• Patients enrolled in other clinical trials or incompliant of regular follow up.
• Patients who did not provide an informed consent.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Officials

• Gang Jin, MD

  Changhai Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Doctor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: March 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)