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

NCT07828756 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-XBZ-PC-K03
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  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)

  After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.

• R0 Resection Rate

  After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.

• Incidence of Adverse Events

  From the time of informed consent signature through 30 days after last study drug administration.

• Disease Control Rate (DCR)

  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..

Study Arms (3)

Chort 1

EXPERIMENTAL

Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, Treatment will continue until disease progression or intolerable toxicity.

Drug: Cisplatin; Drug: Albumin-bound Paclitaxel (Ⅱ); Drug: Capecitabine; Drug: Gemcitabine

Chort 2

EXPERIMENTAL

Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, with a maximum of 12 treatment cycles.

Drug: Cisplatin; Drug: Albumin-bound Paclitaxel (Ⅱ); Drug: Capecitabine; Drug: Gemcitabine

Chort 3

EXPERIMENTAL

Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q3w, for a total treatment duration of up to 6 months.

Drug: Albumin-bound Paclitaxel (Ⅱ); Drug: Capecitabine; Drug: Gemcitabine

Interventions

Cisplatin DRUG

Cisplatin: 30 mg/m² , d1

Chort 1; Chort 2

Albumin-bound Paclitaxel (Ⅱ) DRUG

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

Chort 1; Chort 2

Capecitabine DRUG

Capecitabine 625 mg/m²，po，bid, d1-14

Chort 1; Chort 2

Gemcitabine DRUG

Gemcitabine 800 mg/m², d1

Chort 1; Chort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cisplatin; Albumin-Bound Paclitaxel; Capecitabine; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Jihui Hao

CONTACT

022-2340123-3077; 18622221120@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)