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.
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.
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).
This study will enroll adult patients with histologically confirmed advanced biliary tract cancer or pancreatic cancer, who are experiencing moderate to severe cancer-related abdominal pain and are candidates for first-line systemic therapy combined with celiac plexus neurolysis for pain management. Key inclusion criteria involve specific pain intensity, performance status, and organ function requirements.
Cohort
Prospective
First-Line Systemic Therapy
DrugStandard 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.
Celiac Plexus Neurolysis (CPN)
Procedure/SurgeryAn 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.
Objective Response Rate (ORR)
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) during the period from the start of first-line systemic therapy combined with celiac plexus neurolysis (CPN) until disease progression or the end of follow-up (up to 2 years). Tumor assessments will be performed via contrast-enhanced CT or MRI scans at baseline and every 8-12 weeks thereafter.
Progression-Free Survival (PFS)
The time from the start of combination therapy to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first. The median PFS and its 95% confidence interval (CI) will be estimated using the Kaplan-Meier method. PFS rates at 6, 9, and 12 months will be calculated and compared using the stratified log-rank test. Hazard ratios and 95% CIs will be estimated using a stratified Cox proportional hazards model.
Overall Survival (OS)
The time from the start of combination therapy to death from any cause.
Change in Pain Intensity (Numerical Rating Scale, NRS)
The change in the 11-point Numerical Rating Scale (NRS) score for average abdominal pain intensity (ranging from 0 \[no pain\] to 10 \[worst pain imaginable\]) from baseline to 4, 8, and 12 weeks after the initiation of combination therapy. A negative change indicates pain reduction. Comparisons will be made using paired t-tests.
Change in Quality of Life (QoL) Scores (EORTC QLQ-C30)
The change in the global health status / quality of life scale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) from baseline to 12 and 24 weeks after the initiation of combination therapy.
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