RECRUITINGOBSERVATIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-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). - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 and an estimated life expectancy of ≥ 3 months. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments Being Tested

DRUG

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 standard of care.

PROCEDURE

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.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China