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

NCT07326137 | Recruiting

• 1 other identifier: TJ-IRB202512171
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Pancreatic Cancers; Cancer-related Pain; Advanced Biliary Tract Cancer(BTC)

Outcome Measures

Primary Outcomes (1)

• 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.

  From the start of combination therapy until the first documented disease progression or the end of follow-up, assessed up to 2 years.

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  From the start of combination therapy until the first documented progression or death from any cause, assessed up to 2 years.

• Overall Survival (OS)

  From the start of combination therapy until death from any cause, assessed up to 3 years.

• Change in Pain Intensity (Numerical Rating Scale, NRS)

  Baseline, and at 4, 8, and 12 weeks after the start of combination therapy.

• Change in Quality of Life (QoL) Scores (EORTC QLQ-C30)

  Baseline, and at 12 and 24 weeks after the start of combination therapy.

Study Arms (2)

Advanced Biliary Tract Cancer Cohort

Patients with histologically confirmed advanced biliary tract cancer (including cholangiocarcinoma) who are scheduled to receive first-line systemic therapy combined with celiac plexus neurolysis (CPN) for cancer-related pain.

Drug: First-Line Systemic Therapy; Procedure: Celiac Plexus Neurolysis (CPN)

Advanced Pancreatic Cancer Cohort

Patients with histologically confirmed advanced pancreatic cancer (including pancreatic ductal adenocarcinoma) who are scheduled to receive first-line systemic therapy combined with celiac plexus neurolysis (CPN) for cancer-related pain.

Drug: First-Line Systemic Therapy; Procedure: Celiac Plexus Neurolysis (CPN)

Interventions

Celiac Plexus Neurolysis (CPN) PROCEDURE

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.

Advanced Biliary Tract Cancer Cohort; Advanced Pancreatic Cancer Cohort

First-Line Systemic Therapy DRUG

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.

Advanced Biliary Tract Cancer Cohort; Advanced Pancreatic Cancer Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Dr. Wu, M.D.

CONTACT

13636076910; 255001907@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: December 26, 2025
• Primary Completion (Estimated): June 26, 2028
• Study Completion (Estimated): December 26, 2028
• Last Updated: February 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)