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

NCT05035147 | Recruiting Phase 4

• 1 other identifier: TJGI-003
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

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

  through study completion, an average of 5year

Secondary Outcomes (3)

• Disease Control Rate(DCR)

  through study completion, an average of 5year

• Objective response rate(ORR)

  through study completion, an average of 5year

• Overall survival(OS)

  through study completion, an average of 5year

Study Arms (2)

Low dose strength: albumin-bound paclitaxel + gemcitabine

EXPERIMENTAL

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

Drug: albumin-bound paclitaxel

High dose strength: albumin-bound paclitaxel + gemcitabine

ACTIVE COMPARATOR

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

Drug: albumin-bound paclitaxel

Interventions

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

Also known as: gemcitabine

High dose strength: albumin-bound paclitaxel + gemcitabine; Low dose strength: albumin-bound paclitaxel + gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Rui Liu

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ji zhi, professor

  Tianjin Medical University Cancer Institute and Hospital

  STUDY DIRECTOR

Central Study Contacts

Liu rui, professor

CONTACT

13602139003; Liurui9003@163.com

Ji zhi, professor

CONTACT

18526643284; jizhikey@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 5, 2021
• Study Start: March 25, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 21, 2021

Record last verified: 2021-07

Locations

CN (1)