Actively Recruiting
Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-01-30
128
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open-label, randomized controlled trial that enrolled previously untreated patients with locally advanced or metastatic pancreatic cancer. Participants were randomly assigned to receive either albumin-bound paclitaxel and gemcitabine, or albumin-bound paclitaxel, gemcitabine, and S-1 as first-line treatment. After patients who met the inclusion criteria signed an informed consent form, the study observed patients from the start of treatment until death, withdrawal of consent, loss to follow-up, or the end of the study. Eligible participants were randomly assigned in a 1:1 ratio to either the albumin-bound paclitaxel and gemcitabine treatment group (AG ) or the albumin-bound paclitaxel, gemcitabine, and S-1 treatment group (GAS). A total of 128 patients were planned for inclusion in the study, with 64 in each treatment group. Baseline data related to demographics, disease, treatment, adverse events, and tumor status were collected by the treating physician during the first visit and follow-up visits. Follow-up visits were conducted according to a fixed schedule, with survival assessed every three months through phone calls, WeChat, or by contacting other physicians. The final visit recorded patient death, withdrawal of consent, loss to follow-up, or the conclusion of the study.
CONDITIONS
Official Title
Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant voluntarily agrees to participate and signs informed consent.
- Participant is 18 years old or older at the time of consent.
- Pathological diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
- No prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
- If prior neoadjuvant/adjuvant chemoradiotherapy or chemotherapy was given, at least 6 months have passed since treatment end before disease progression/recurrence.
- Measurable lesions per RECIST 1.1; if only one lesion, it must not have been previously irradiated or must show significant progression since radiotherapy.
- ECOG performance status of 0 to 2.
- Life expectancy over 3 months.
- Able to take oral chemotherapy.
- Meets required organ function criteria.
- Females of childbearing potential and males with partners of childbearing potential agree to use effective contraception from 7 days before randomization until 24 weeks after treatment start.
- Female participants have a negative serum pregnancy test within 7 days prior to randomization.
You will not qualify if you...
- Untreated active brain metastases or leptomeningeal metastasis (unless previously treated and stable for at least 4 weeks with no new neurological symptoms).
- Untreated spinal compression fractures (treated fractures must be stable for at least 2 weeks).
- Prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
- If prior neoadjuvant/adjuvant chemoradiotherapy or chemotherapy was given, less than 6 months have passed since treatment end before disease progression/recurrence.
- High risk of gastrointestinal or abdominal bleeding.
- Uncontrolled cancer pain requiring escalation of analgesics at enrollment.
- Received chemotherapy, small molecule inhibitors, immunotherapy, or other anti-cancer treatments within 28 days before enrollment.
- Used traditional Chinese medicine with anti-cancer indications within 14 days before enrollment.
- Major surgery within 28 days before enrollment (excluding diagnostic biopsies).
- Received radical radiation therapy within last 3 months (palliative radiation allowed if at least 2 weeks before treatment).
- History of other malignancy within 5 years except certain treated cancers.
- Uncontrolled comorbidities including active HBV/HCV infection with viral load above specified thresholds, HIV/AIDS, active syphilis, tuberculosis, infections, uncontrolled hypertension, symptomatic heart failure NYHA II-IV, unstable angina, recent myocardial infarction, QTc prolongation or arrhythmia risk.
- Active bleeding.
- Toxicity from prior anti-cancer treatments not recovered to CTCAE grade 1 (except alopecia and peripheral neuropathy recovered to grade 2).
- Breastfeeding women.
- Conditions affecting safety, compliance, or study reliability including psychiatric disorders, moderate to severe ascites, pleural or pericardial effusion.
- Vulnerable populations unable to provide informed consent or comply with study requirements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chaoyang District, China, 100021
Actively Recruiting
Research Team
L
Lin Yang, Doctor
CONTACT
L
Lin Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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