Clinical trial NCT05035147: Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pancreatic Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age: ≥18 years old, no gender limit;
2. Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology;
3. 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.;
4. 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);
5. 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;
6. The subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up

Exclusion Criteria:

1. Pregnant or lactating women;
2. 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;
3. Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients.
4. The patient has clinically significant ascites;
5. Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
6. Patients with active hepatitis B or C;
7. Doctors think it is not suitable for inclusion.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: through study completion, an average of 5year
Secondary outcomes:
measure: Disease Control Rate(DCR)
timeFrame: through study completion, an average of 5year
measure: Objective response rate(ORR)
timeFrame: through study completion, an average of 5year
measure: Overall survival(OS)
timeFrame: through study completion, an average of 5year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Rui Liu
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Ji zhi, professor
role: STUDY_DIRECTOR
References: