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Starting soon Phase 2

Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer

NCT07828756 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-09-30
Last updated
2026-09-18

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Cisplatin →Albumin-bound Paclitaxel (Ⅱ) →Albumin-bound Paclitaxel (Ⅱ) →Capecitabine →Capecitabine →Gemcitabine →Gemcitabine →

Cisplatin: Cisplatin: 30 mg/m² , d1

Albumin-bound Paclitaxel (Ⅱ): Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1

Albumin-bound Paclitaxel (Ⅱ): Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8

Capecitabine: Capecitabine 625 mg/m²,po,bid, d1-14

Capecitabine: Capecitabine 1660 mg/(m² • d), d1-14

Gemcitabine: Gemcitabine 800 mg/m², d1

Gemcitabine: Gemcitabine 1000 mg/m², d1, d8

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18 to 75 years old. * Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or metastatic pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease. Prior neoadjuvant/adjuvant chemotherapy is permitted, provided the interval from completion of prior chemotherapy to study drug administration is more than 6 months. (2) High-risk resectable or borderline resectable pancreatic cancer assessed by a multidisciplinary team.(3) Curative resection (R0 or R1 resection) performed without prior neoadjuvant therapy, and adjuvant treatment can be initiated within 12 weeks postoperatively. * Presence of at least one measurable lesion per RECIST v1.1 (exclusive to participants in Cohort 3). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Estimated survival time ≥ 3 months. * Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L. * Adequate liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤5×ULN allowed in patients with liver metastases); total bilirubin ≤ 1.5×ULN. * Adequate renal function: serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min (calculated by Cockroft-Gault formula). * Adequate coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN. * Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to enrollment, be non-lactating, and agree to use effective contraception throughout the study and for 6 months after the last study treatment. Male participants must agree to effective contraception during the study and for 6 months after study completion. * Able to understand the study information; participant or legal representative voluntarily provides written informed consent. Exclusion Criteria: * History of other malignant tumors within the past 5 years * Known hypersensitivity or intolerance to any study drug or excipients. * Confirmed homozygous or compound heterozygous DPYD variants leading to complete dihydropyrimidine dehydrogenase (DPD) deficiency. * Presence of any of the following comorbidities: ① Severe or uncontrolled cardiovascular disease: New York Heart Association (NYHA) Class II or higher chronic heart failure, uncontrolled hypertension (systolic BP \>150 mmHg and/or diastolic BP \>90 mmHg despite stable medication), etc. ② Severe respiratory disorders: asthma requiring inhaled/systemic glucocorticoids, active chronic obstructive pulmonary disease, etc. ③ Confirmed neurological diseases (epilepsy, dementia, etc.) or Grade ≥2 peripheral sensory/motor neuropathy. ④ Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L under stable treatment). ⑤ Severe chronic or active infections requiring ≥1 consecutive week of systemic antibacterial, antifungal or antiviral therapy (including tuberculosis). ⑥ Active HIV infection (HIV antibody positive); untreated active HBV (HBsAg/HBcAg positive with HBV-DNA above institutional upper limit of normal) or active HCV infection (HCV antibody positive with HCV-RNA above institutional upper limit of normal). * Untreated active brain metastases (including symptomatic brain or leptomeningeal metastases). Participants with brain metastases are eligible only if brain lesions are stable on imaging performed ≥4 weeks prior to first study dose, no new neurological symptoms or baseline symptom relapse, and no systemic steroid administration for ≥14 days before study treatment initiation, with no evidence of new or enlarged metastatic lesions. * Medical history as follows: ① Major abdominal/thoracic surgery within 28 days prior to first study dose, or planned major surgery during the study period (diagnostic puncture and infusion port implantation excluded). ② Severe cardiovascular/cerebrovascular events (myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to enrollment; clinically silent lacunar infarcts are permitted. * History of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment. * Inability to swallow or untreated malabsorption syndrome. * Receipt of any investigational product within 1 month prior to enrollment. * Any other condition judged by the investigator to render the participant unsuitable for study participation.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — 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) — 12 months after signing informed consent, until first EFS event or loss to follow-up.
  • Recommended Phase 2 Dose (RP2D) — After all participants in each dose cohort complete the 21-day DLT observation period.
  • Disease-Free Survival (DFS) — From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute & Hospital Tianjin China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07828756 on ClinicalTrials.gov ↗ ← All trials in China