Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The Objectives of this clinical trial is to evaluate the efficacy and safety of tumor treating fields combined with gemcitabine and albumin bound paclitaxel in the treatment of locally advanced pancreatic cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Subjects aged between 18 and 75 (including 18 and 75) of both genders;

• Expected survival time ≥3 months;

• Pancreatic adenocarcinoma confirmed by histology/cytology;

• Locally advanced lesions meeting any of the following criteria without distant metastasis: ① Pancreatic head and neck tumors: a. The tumor invaded the Superior Mesenteric Artery (SMA) more than 180°; b. The tumor invaded the celiac trunk more than 180°; c. Unresectable reconstruction of superior mesenteric vein or portal vein due to tumor invasion or embolism (tumor thrombus or thrombus); d. The tumor extensively invaded the distal jejunal drainage branch of the superior mesenteric vein. ② Pancreatic body/tail tumor: a. The tumor invaded the superior mesenteric artery or celiac trunk more than 180°; b. Celiac trunk and abdominal aorta involvement; c. The superior mesenteric vein or portal vein cannot be resected and reconstructed due to tumor invasion or embolism (tumor thrombus or thrombus).

• At least one measurable lesion according to revised RECIST version 1.1;

• ECOG score 0-1;

• Be able to receive gemcitabine for injection and paclitaxel for injection (albumin-bound) combined therapy according to medical advice;

• Able to operate tumor treating fields independently or with the help of nursing staff;

• AE should be restored to normal or CTCAE1 grade after previous treatment;

⁃ The serum pregnancy test results of female subjects of reproductive age were negative. Female subjects of reproductive age agree to use effective contraception (e.g. hormonal or barrier methods or abstinence) during the study period and for 6 months after the last dose of chemotherapy drugs;

⁃ Male subjects agree to use effective birth control (such as barrier method or abstinence) and not to donate sperm during the study and within 3 months after the last chemotherapy drug administration;

⁃ Voluntarily sign the informed consent.

Locations
Other Locations
China
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Fudan University Affiliated Huashan Hospital
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Huashan Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Fu
Surgeonfu@163.com
021-52889999
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2027-09-28
Participants
Target number of participants: 512
Treatments
Experimental: Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel
Device: Tumor treating fields Subjects will use tumor treating fields each day~Drug: Gemcitabine hydrochloride and albumin binding paclitaxel 28 days is a cycle. On the 1st, 8th and 15th days of each cycle, 125 mg/m2 albumin binding paclitaxel will be administered intravenously,1000 mg/m2 gemcitabine hydrochloride will be administered immediately after the infusion of albumin binding paclitaxel.
Active_comparator: Gemcitabine hydrochloride and albumin binding paclitaxel
Drug: Gemcitabine hydrochloride and albumin binding paclitaxel 28 days is a cycle. On the 1st, 8th and 15th days of each cycle, 125 mg/m2 albumin binding paclitaxel will be administered intravenously,1000 mg/m2 gemcitabine hydrochloride will be administered immediately after the infusion of albumin binding paclitaxel.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

This content was sourced from clinicaltrials.gov