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

September 15, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

A Multi-cohort Exploratory Study to Evaluate the Efficacy and Safety of Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chort 1
Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, Treatment will continue until disease progression or intolerable toxicity.
Drug: Cisplatin
Cisplatin: 30 mg/m² , d1
Drug: Albumin-bound Paclitaxel (Ⅱ)
Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1
Drug: Albumin-bound Paclitaxel (Ⅱ)
Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8
Drug: Capecitabine
Capecitabine 625 mg/m²，po，bid, d1-14
Drug: Capecitabine
Capecitabine 1660 mg/(m² • d), d1-14
Drug: Gemcitabine
Gemcitabine 800 mg/m², d1
Drug: Gemcitabine
Gemcitabine 1000 mg/m², d1, d8
Experimental: Chort 2
Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, with a maximum of 12 treatment cycles.
Drug: Cisplatin
Cisplatin: 30 mg/m² , d1
Drug: Albumin-bound Paclitaxel (Ⅱ)
Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1
Drug: Albumin-bound Paclitaxel (Ⅱ)
Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8
Drug: Capecitabine
Capecitabine 625 mg/m²，po，bid, d1-14
Drug: Capecitabine
Capecitabine 1660 mg/(m² • d), d1-14
Drug: Gemcitabine
Gemcitabine 800 mg/m², d1
Drug: Gemcitabine
Gemcitabine 1000 mg/m², d1, d8
Experimental: Chort 3
Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q3w, for a total treatment duration of up to 6 months.
Drug: Albumin-bound Paclitaxel (Ⅱ)
Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1
Drug: Albumin-bound Paclitaxel (Ⅱ)
Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8
Drug: Capecitabine
Capecitabine 625 mg/m²，po，bid, d1-14
Drug: Capecitabine
Capecitabine 1660 mg/(m² • d), d1-14
Drug: Gemcitabine
Gemcitabine 800 mg/m², d1
Drug: Gemcitabine
Gemcitabine 1000 mg/m², d1, d8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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..
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-XBZ-PC-K03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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