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Clinical Trials in China / NCT07828756
Starting soon Phase 2

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

NCT07828756 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Phase 2
Started
2026-09-30
Last updated
2026-09-18

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

CisplatinAlbumin-bound Paclitaxel (Ⅱ)Albumin-bound Paclitaxel (Ⅱ)CapecitabineCapecitabineGemcitabineGemcitabine

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)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute & Hospital Tianjin China

More Tianjin Medical University Cancer Institute and Hospital trials in China

Other trials for the same condition

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