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

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cisplatin

    Drug

    Cisplatin: 30 mg/m² , d1

  • Albumin-bound Paclitaxel (Ⅱ)

    Drug

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

  • Albumin-bound Paclitaxel (Ⅱ)

    Drug

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

  • Capecitabine

    Drug

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

  • Capecitabine

    Drug

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

  • Gemcitabine

    Drug

    Gemcitabine 800 mg/m², d1

  • Gemcitabine

    Drug

    Gemcitabine 1000 mg/m², d1, d8

Treatment groups

147 Participants
are divided into 3 treatment groups
Group A: Chort 1Experimental treatment 4 interventions
Group B: Chort 2Experimental treatment 4 interventions
Group C: Chort 3Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.
2

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.
3

Recommended Phase 2 Dose (RP2D)

Time frame
After all participants in each dose cohort complete the 21-day DLT observation period.
4

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.

Secondary outcomes

1

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.
2

Maximum Tolerated Dose (MTD)

Time frame
After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.
3

R0 Resection Rate

Time frame
After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.
4

Incidence of Adverse Events

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: