Randomized Phase II Clinical Study of Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
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.
• The participant must voluntarily agree to participate in the study and sign the informed consent form.
• The participant must be ≥18 years old on the day of signing the informed consent form.
• The participant must have a pathological diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
• The participant must not have received any prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
• Note: Patients who have received neoadjuvant/adjuvant/radical chemoradiotherapy or neoadjuvant/adjuvant chemotherapy are eligible only if the time from the end of treatment to the first diagnosis of disease progression/recurrence is at least 6 months.
• The participant must have measurable lesions according to RECIST 1.1 criteria. If there is only one measurable lesion at baseline, it must not have been previously irradiated or there must be evidence of significant progression since the end of radiotherapy.
• The participant must have an ECOG performance status score of 0-2. The participant must have a life expectancy of more than 3 months. The participant must be able to take oral chemotherapy. The participant must meet the required organ function criteria before inclusion.
• Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use highly effective contraception starting 7 days before randomization and continue until 24 weeks after treatment initiation. Female participants must have a negative serum pregnancy test within 7 days prior to randomization.