This is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG). Cohort 2 enrolls 27 patients with borderline-resectable or high-risk resectable pancreatic cancer, who will receive neoadjuvant therapy with the PAXG regimen. Cohort 3 enrolls patients with pancreatic cancer who have undergone curative resection, who will receive adjuvant therapy with nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine. Objectives of Study: To evaluate the efficacy and safety of nab-paclitaxel (Ⅱ)-based regimes for pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Cisplatin: 30 mg/m² , d1
Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1
Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8
Capecitabine 625 mg/m²,po,bid, d1-14
Capecitabine 1660 mg/(m² • d), d1-14
Gemcitabine 800 mg/m², d1
Gemcitabine 1000 mg/m², d1, d8
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Progression-Free Survival (PFS)
Time frame: Time from subject's first study drug administration to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 5.5 months.
1-Year Event-Free Survival Rate (1y-EFS Rate)
Time frame: 12 months after signing informed consent, until first EFS event or loss to follow-up.
Recommended Phase 2 Dose (RP2D)
Time frame: After all participants in each dose cohort complete the 21-day DLT observation period.
Disease-Free Survival (DFS)
Time frame: From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.
Objective Response Rate (ORR)
Time frame: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months.
Maximum Tolerated Dose (MTD)
Time frame: After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.
R0 Resection Rate
Time frame: After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.
Incidence of Adverse Events
Time frame: From the time of informed consent signature through 30 days after last study drug administration.
Disease Control Rate (DCR)
Time frame: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months..
Overall Survival (OS)
Time frame: Time from subject's first study drug administration to death from any cause, assessed up to 40 months.
Dose-Limiting Toxicity (DLT)
Time frame: After all participants in each dose cohort complete the 21-day DLT observation period.
Event-Free Survival (EFS)
Time frame: From informed consent signature to first local recurrence, distant metastasis, tumor progression, second malignancy or all-cause death (whichever occurs first), assessed up to 16 months.
Major Pathological Response (MPR) Rate
Time frame: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.
Pathological Complete Response (pCR) Rate
Time frame: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.
Duration of Response (DOR)
Time frame: Time from first documented CR or PR to subsequent disease progression or death from any cause, whichever occurs first, until end-of-follow-up, assessed up to 6 months.
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