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

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

albumin-bound paclitaxel

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rui LiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low dose strength: albumin-bound paclitaxel + gemcitabine

High dose strength: albumin-bound paclitaxel + gemcitabine

Arm Description

albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8 q3w

albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8,15 q4w

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

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

Secondary Outcome Measures

Disease Control Rate(DCR)

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

Objective response rate(ORR)

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)

Overall survival(OS)

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

Full Information

NCT ID

NCT05035147

First Posted

August 16, 2021

Last Updated

September 14, 2021

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05035147

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2021 (Actual)

Primary Completion Date

April 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

934 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose strength: albumin-bound paclitaxel + gemcitabine

Arm Type

Experimental

Arm Description

albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8 q3w

Arm Title

High dose strength: albumin-bound paclitaxel + gemcitabine

Arm Type

Active Comparator

Arm Description

albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8,15 q4w

Intervention Type

Drug

Intervention Name(s)

albumin-bound paclitaxel

Other Intervention Name(s)

gemcitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

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

Time Frame

through study completion, an average of 5year

Secondary Outcome Measure Information:

Title

Disease Control Rate(DCR)

Description

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

Time Frame

through study completion, an average of 5year

Title

Objective response rate(ORR)

Description

Time Frame

through study completion, an average of 5year

Title

Overall survival(OS)

Description

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

Time Frame

through study completion, an average of 5year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liu rui, professor

Phone

13602139003

Liurui9003@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ji zhi, professor

Phone

18526643284

jizhikey@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ji zhi, professor

Organizational Affiliation

Tianjin Medical University Cancer Institute & Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Rui Liu

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui Liu

Phone

13602139003

liurui9003@163.com

12. IPD Sharing Statement

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

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