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NCT Number: NCT05035147

Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer

This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rui Liu

Tianjin, Tianjin Municipality, 300000, China

Location status: Recruiting

Location contact

About this study

Pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.The prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.Albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. It has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.It is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥18 years old, no gender limit;
  • Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology;
  • The patient has not undergone standard systemic treatment in the past, or more than half a year after the end of postoperative treatment.For those who have undergone major surgery or radiotherapy, the interval must be more than 4 weeks and their metastases have not received any local treatment including radiotherapy, chemotherapy, surgical treatment, etc.;
  • At least one measurable lesion (CT scan of tumor lesions with long diameter ≥ 10 mm, CT scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness not greater than 6 mm);
  • The main organs are functioning normally, that is, they meet the following standards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14 days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALB in 14 days), TBIL <1.5 times the upper limit of normal (ULN);ALT and AST≤3ULN, accompanied by liver metastasis, then ALT and AST<5×ULN;Cr ≤1.5×ULN or creatinine clearance rate ≥60ml/min;
  • The subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up

Exclusion criteria

  • Pregnant or lactating women;
  • Patients suffering from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
  • Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients.
  • The patient has clinically significant ascites;
  • Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
  • Patients with active hepatitis B or C;
  • Doctors think it is not suitable for inclusion.

Treatment and study plan

Albumin-bound paclitaxel

Drug

Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth days, with a four-week cycle

Other names: gemcitabine

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: through study completion, an average of 5year

    From date of randomization until the date of first documented progression or date of death from any cause

Secondary outcomes

  1. Disease Control Rate(DCR)

    Time frame: through study completion, an average of 5year

    The percentage of confirmed complete remission, partial remission and stable disease among patients with evaluable efficacy

  2. Objective response rate(ORR)

    Time frame: through study completion, an average of 5year

    The proportion of patients whose tumors have shrunk to a certain level and maintained for a certain period of time, including CR and PR cases.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.The subject must have measurable tumor lesions at baseline.According to the RECIST 1.1 standard, the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable (SD), and progress (PD)

  3. Overall survival(OS)

    Time frame: through study completion, an average of 5year

    From date of randomization until the date of death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Ji zhi, professor

CONTACT

[email protected]

18526643284

Liu rui, professor

CONTACT

[email protected]

13602139003

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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