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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Healthy Life Innovation Medical Technology Co., Ltd

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

The subjects has previously received first-line treatment for pancreatic adenocarcinoma;

Subjects with contraindications to treatment with gemcitabine for injection and/or paclitaxel for injection (albumin-bound) or known severe allergies to gemcitabine for injection and/or paclitaxel for injection (albumin-bound);

Patients had cancer requiring other antitumor therapy within 2 years before enrollment, excluding treated stage I prostate cancer, cervical cancer in situ, breast cancer in situ, and non-melanoma skin cancer;

Abnormal bone marrow, heart, liver and kidney function: a. Neutrophil count < 1.5 × 10^9/L, platelet count < 100 × 10^9/L, hemoglobin < 90g/L; The use of blood transfusion, platelet transfusion and erythropoietin was prohibited within 14 days before C1D1, and the use of Leukocytotropic drug such as G-CSF, fegrasstim, pefegrasstim, etc., was prohibited within 7 days before C1D1.b. Total bilirubin > 1.5× Upper Limit of Normal (ULN); Subjects with a total bilirubin > 2×ULN that is elevated due to pancreatic cancer compression of the bile duct but has been fitted with a bile duct stent for drainage can be enrolled. AST and/or ALT> 2.5×ULN; the use of drugs that improve liver function, such as reducing transaminase was prohibited within 7 days before C1D1. c. Serum creatinine > 1.5×ULN; d. A history of severe cardiovascular disease, including but not limited to second or third degree heart block; Severe ischemic heart disease; New York Heart Association (NYHA) class II or higher congestive heart failure (mild physical activity limitation; Comfortable at rest, but normal activities can cause fatigue, palpitations, or difficulty breathing);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxel

    Device

    Device: Tumor treating fields Subjects will use tumor treating fields until disease progression or for a maximum of 30 months. Drug: Gemcitabine hydrochloride and albumin binding paclitaxel Subjects will receive Gemcitabine hydrochloride and albumin binding paclitaxel until disease progression or for a maximum of 30 months.

  • Gemcitabine hydrochloride and albumin binding paclitaxel

    Drug

    Drug: Gemcitabine hydrochloride and albumin binding paclitaxel Subjects will receive Gemcitabine hydrochloride and albumin binding paclitaxel until disease progression or for a maximum of 30 months.

Treatment groups

512 Participants
are divided into 2 treatment groups
Group A: Tumor treating fields combined with Gemcitabine hydrochloride and albumin binding paclitaxelExperimental treatment 2 interventions
Group B: Gemcitabine hydrochloride and albumin binding paclitaxelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

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

Time frame
up to 12 months after the last study treatment

Secondary outcomes

1

Number of participants with adverse events (AEs)

Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments

Time frame
The whole study period
2

Progression-free survival (PFS)

Progression-free survival is defined as the time from the start of treatment with Tumor Treating Fields and Docetaxel until the first documentation of disease progression or death due to any cause, whichever occurs first

Time frame
up to 30 months
3

12-month OS rate

12-month Overall survival rate

Time frame
12 months
4

Progression Free Survival rate at 6 months

The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment

Time frame
6 months

Other outcomes

Sponsors and contacts

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