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Recruiting Phase 3 NCT05653453

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

Trial Parameters

Condition Locally Advanced Pancreatic Cancer
Sponsor Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 512
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-12-20
Completion 2026-12-25
Interventions
Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxelGemcitabine hydrochloride and albumin binding paclitaxel

Brief 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 Criteria

Inclusion Criteria: 1. Subjects aged between 18 and 75 (including 18 and 75) of both genders; 2. Expected survival time ≥3 months; 3. Pancreatic adenocarcinoma confirmed by histology/cytology; 4. 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).

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