Celiac plexus block plus first-line systemic therapy 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

This study will try giving a celiac plexus block alongside standard first-line cancer drugs to see if it reduces pain and helps people with advanced bile duct or pancreatic cancer.

Quick facts

• Study type: Observational
• Enrollment: 103 (estimated)
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07326137 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center observational cohort of adults with inoperable advanced biliary tract or pancreatic cancer who have moderate to severe abdominal pain and are scheduled for first-line systemic therapy. Participants who undergo celiac plexus neurolysis (CPN) will be followed alongside a contemporary control cohort receiving systemic therapy alone, with treatment choices made by the treating physicians per routine practice. Co-primary endpoints are pain response (≥2-point drop on the Numeric Rating Scale or ≥50% opioid reduction sustained 4 weeks) and objective tumor response by RECIST 1.1, and secondary endpoints include progression-free survival, overall survival, quality of life, and safety. Patients will be followed for up to two years to capture pain control, oncologic outcomes, and adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed inoperable advanced biliary tract or pancreatic cancer who have cancer-related abdominal pain (NRS ≥4 for >1 week), are planned for first-line systemic therapy, have ECOG 0–2 and an expected survival of at least 3 months, and have no prior CPN.

Not a fit: Patients with contraindications to CPN, prior celiac plexus neurolysis, severe cardiac/hepatic/renal impairment, coagulation disorders, or very limited life expectancy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, combining CPN with first-line systemic therapy could provide better pain relief, reduce opioid needs, and improve quality of life while allowing standard cancer treatment to continue.

How similar studies have performed: Celiac plexus neurolysis has been shown in prior studies to reduce pain in pancreatic cancer, but prospectively combining CPN with first-line systemic therapy for biliopancreatic cancers in a comparative cohort is relatively untested.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Yang Dr. Wu, M.D.

Conditions: Advanced Biliary Tract Cancer, Advanced Pancreatic Cancers, Cancer-related Pain