Actively Recruiting
First-Line Systemic Therapy Combined With Celiac Plexus Blockade for Advanced Biliopancreatic Cancer With Pain: A Prospective Observational Study
Led by Tongji Hospital · Updated on 2026-02-11
103
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating patients with advanced bile duct or pancreatic cancer who experience pain from their disease. This study aims to learn about the effects of combining a standard pain relief procedure called Celiac Plexus Block with standard first-line cancer drug treatments. The purpose is to see if starting cancer treatment together with this specialized pain management leads to better pain control and cancer outcomes compared to standard treatments alone. Participants will receive the Celiac Plexus Neurolysis (CPN) procedure, which involves injecting a neurolytic agent to block pain signals from the upper abdomen. After this, they will begin their standard systemic therapy, which may include drugs like Durvalumab, Pembrolizumab, Gemcitabine, Cisplatin, or FOLFIRINOX regimens depending on cancer type and physician choice. Treatment decisions follow routine clinical practice, and the study observes the combined approach without altering standard care. During the study, participants will be followed for up to 2 years with regular assessments of pain levels, opioid use, tumor imaging, lab tests, and quality of life questionnaires. Researchers will monitor pain response, tumor response, survival outcomes, and safety related to both the pain procedure and cancer treatments. This long-term follow-up aims to provide real-world evidence on how well integrating pain management with cancer therapy works in this patient group.
CONDITIONS
Brief Title
A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade for Advanced Biliopancreatic Cancer With Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced biliopancreatic malignancy (including biliary tract cancer or pancreatic cancer)
- Moderate to severe cancer-related abdominal pain with a Numeric Rating Scale pain score of 4 or higher for more than 1 week
- Scheduled to receive first-line systemic therapy such as PD-1/PD-L1 inhibitors alone or with chemotherapy/targeted therapy
- ECOG Performance Status of 0 to 2 and estimated life expectancy of at least 3 months
You will not qualify if you...
- Previous history of celiac plexus neurolysis or ablation
- Coagulation disorders with INR greater than 1.5 or platelet count below 50 x 10⁹/L
- Severe heart, liver, or kidney failure (Child-Pugh Class C, eGFR less than 30 mL/min, or NYHA Class III-IV heart failure)
- Contraindications to celiac plexus block such as local infection or anatomical variation
- Any other condition that the investigator believes would prevent safe participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who undergo routine care with first-line systemic therapy combined with celiac plexus neurolysis (CPN) are observed. Clinical data including pain scores, analgesic usage, tumor imaging assessments, and laboratory results are collected to evaluate treatment outcomes and safety.
Assessments at baseline, and at 4, 8, 12, 24, and up to 2 years as per clinical practice
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Y
Yang Dr. Wu, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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