Actively Recruiting
Irinotecan Liposome Combined With Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer Phase II Study
Led by Junjie Hang · Updated on 2025-02-14
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new second-line treatment for advanced pancreatic cancer, a highly aggressive cancer with poor prognosis and limited treatment options after standard therapy fails. This phase II study aims to evaluate the effectiveness and safety of combining irinotecan liposome chemotherapy with capecitabine for patients whose cancer has progressed after initial treatment. The study builds on previous research showing potential benefits of these drugs in similar patient populations. Participants will receive irinotecan liposome through intravenous infusion every two weeks, alongside oral capecitabine taken twice daily for one week followed by a one-week break. Each two-week cycle is considered one treatment cycle, with an expected total of six cycles. After this treatment phase, maintenance therapy may be given based on the investigator's decision until the disease worsens or side effects become intolerable. During the study, patients will undergo screening with baseline exams, followed by close monitoring throughout the treatment cycles to assess safety, tolerability, and response. After completing treatment, participants will enter a 12-month follow-up period to track progression-free survival and any safety concerns. The study will measure outcomes including time without disease progression, response rates, disease control, and overall survival up to one year.
CONDITIONS
Brief Title
Irinotecan Liposome in Combination With Capecitabine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Histopathologically confirmed unresectable or metastatic pancreatic cancer
- Tumor progression confirmed by imaging after prior standard first-line treatment
- At least one measurable target lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Expected survival time of at least 3 months
- Adequate blood counts: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L without recent transfusion or stimulating factors
- Liver and kidney function within defined limits (serum creatinine ≤1.5x upper normal limit; AST and ALT ≤2.5x upper normal limit or ≤5x if liver metastases; total bilirubin ≤1.5x or ≤3x if liver metastases)
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during and for 6 months after the trial
- Voluntary participation with signed informed consent
You will not qualify if you...
- Hypersensitivity to study drugs or components
- Serious uncontrolled infections or diseases, including moderate to severe renal impairment
- Significant cardiac conditions such as long QTc syndrome, severe arrhythmias, low ejection fraction (<50%), recent myocardial infarction or unstable angina
- Active hepatitis B or C infection (except asymptomatic carriers)
- HIV infection
- Intestinal obstruction confirmed by imaging
- Other concurrent malignancies except certain controlled skin or in situ cancers
- Pregnancy, lactation, or refusal to use contraception if of childbearing potential
- Other malignant tumors requiring treatment
- Recent history of pulmonary hemorrhage or severe bleeding
- Symptomatic brain or meningeal metastases, spinal cord tumor invasion or compression
- Use of strong CYP3A4, CYP2C8, or UGT1A1 inhibitors or inducers within 14 days before study drug
- Participation in other clinical trials within 1 month before first dose
- Investigator’s judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 2-week cycles for an expected 6 cycles, continuing until disease progression or intolerable toxicity
Participants receive liposomal irinotecan by intravenous infusion every 2 weeks combined with oral capecitabine taken twice daily for 7 days followed by a 7-day break. This 2-week period constitutes one treatment cycle with an expected 6 cycles. Treatment continues until disease progression or intolerable toxicity occurs.
1 visit every 2 weeks during treatment cycles
Duration - Up to 12 months
Participants are monitored for safety and progression-free survival after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Shenzhen, Guangdong, China, 518100
Actively Recruiting
Research Team
J
Junjie Hang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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