A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade for Advanced Biliopancreatic Cancer With Pain

Официальное название

A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade in Patients With Advanced Biliopancreatic Malignancies and Cancer-Related Pain

Обзор

This study is for patients with advanced bile duct or pancreatic cancer who are experiencing pain from their disease. The purpose of this research is to learn about the effects of combining a standard pain relief treatment (Celiac Plexus Block) with standard first-line cancer drugs. Patients in this study will receive the Celiac Plexus Block procedure, which is intended to reduce pain, and will then begin their standard cancer medication regimen. Researchers will observe and compare how well this combined approach works to control pain and the cancer itself, and will monitor for any side effects. Participation in this study involves being followed by the research team for up to 2 years to track health outcomes. The goal is to see if starting cancer treatment together with this specialized pain management technique is more helpful for patients compared to what is already known about the standard treatments alone.

Подробное описание

This is a prospective, observational, single-center cohort study designed to evaluate the clinical outcomes of integrating celiac plexus neurolysis (CPN) with standard first-line systemic therapy in patients diagnosed with advanced biliopancreatic malignancies and concomitant cancer-related pain.

Eligible participants are adults with histologically confirmed, inoperable advanced biliary tract cancer or pancreatic cancer, who present with moderate to severe abdominal pain and are candidates for first-line systemic treatment. All patients will be managed according to routine clinical practice; the decision to perform CPN and the choice of specific systemic therapy regimen will be determined by the treating physician team based on standard guidelines and individual patient circumstances, not by the study protocol.

The primary objective is to assess the efficacy of this integrated approach, with co-primary endpoints of pain response rate and objective tumor response rate. Pain response is defined as a reduction of ≥2 points in the Numeric Rating Scale score or a ≥50% decrease in opioid consumption sustained for ≥4 weeks. Tumor response will be evaluated per RECIST 1.1 criteria. Secondary objectives include comparing overall survival, progression-free survival, and quality of life metrics between the cohort receiving CPN combined with systemic therapy and a contemporary control cohort receiving systemic therapy alone. Safety will be assessed by monitoring the incidence and severity of adverse events related to both CPN and the systemic treatments.

Clinical data, including pain scores, analgesic usage, tumor imaging assessments, and laboratory results, will be prospectively collected at predefined time points for a follow-up period of up to 2 years. The study aims to provide real-world evidence on whether the early integration of interventional pain management with oncological treatment can improve overall patient outcomes in this population with high symptom burden.

Вмешательства

• Препарат First-Line Systemic Therapy
  Standard first-line systemic therapy regimens for advanced biliopancreatic malignancies, administered according to clinical guidelines. For biliary tract cancer, this may include regimens such as Durvalumab or Pembrolizumab combined with Gemcitabine and Cisplatin. For pancreatic cancer, this may include FOLFIRINOX or mFOLFIRINOX regimens, or Gemcitabine-based combinations. The specific regimen is determined by the treating physician based on the patient's cancer type, performance status, and sta
• Процедура Celiac Plexus Neurolysis (CPN)
  An interventional pain management procedure performed under CT or ultrasound guidance. It involves the injection of a neurolytic agent (such as absolute ethanol or 10% phenol) into the celiac plexus to block the transmission of pain signals from the upper abdomen. This procedure is intended to provide long-term pain relief for patients with advanced biliopancreatic malignancies.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From the start of combination therapy until the first documented disease progression or the end of follow-up, assessed up to 2 years.]

Вторичные конечные точки (4)

• Progression-Free Survival (PFS) [Срок оценки: From the start of combination therapy until the first documented progression or death from any cause, assessed up to 2 years.]
• Overall Survival (OS) [Срок оценки: From the start of combination therapy until death from any cause, assessed up to 3 years.]
• Change in Pain Intensity (Numerical Rating Scale, NRS) [Срок оценки: Baseline, and at 4, 8, and 12 weeks after the start of combination therapy.]
• Change in Quality of Life (QoL) Scores (EORTC QLQ-C30) [Срок оценки: Baseline, and at 12 and 24 weeks after the start of combination therapy.]

Критерии участия

Критерии включения

• Histologically confirmed advanced biliopancreatic malignancy (including biliary tract cancer or pancreatic cancer).
• Cancer-related pain: Baseline Numeric Rating Scale (NRS) pain score ≥ 4 points for over 1 week, with plans to receive celiac plexus neurolysis (CPN).
• Scheduled to receive a first-line systemic treatment regimen (e.g., PD-1/PD-L1 inhibitor monotherapy or in combination with chemotherapy/targeted therapy).
• ECOG Performance Status of 0-2 and an estimated life expectancy of ≥ 3 months.

Критерии исключения

• Previous history of celiac plexus neurolysis or ablation.
• Coagulation disorders (INR > 1.5, platelet count < 50 × 10⁹/L).
• Severe cardiac, hepatic, or renal insufficiency (Child-Pugh Class C, estimated glomerular filtration rate (eGFR) < 30 mL/min, NYHA Class III-IV heart failure).
• Contraindications to celiac plexus block (e.g., local infection, anatomical variation).
• Any other condition that, in the investigator's judgment, would preclude safe participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT07326137 · TJ-IRB202512171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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