Advanced Biliary Tract Cancer(BTC)NCT07326137
A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade for Advanced Biliopancreatic Cancer With Pain
An observational study of Advanced Biliary Tract Cancer(BTC) and Advanced Pancreatic Cancers, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Biliary Tract Cancer(BTC), Advanced Pancreatic Cancers, Cancer-related Pain
- What is being tested?
- First-Line Systemic Therapy and Celiac Plexus Neurolysis (CPN)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 26 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yang Dr. Wu, M.D., 13636076910, 255001907@qq.com
About this study
Official title: 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 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.
Read the detailed description
This is a prospective, observational, single-center cohort study designed to evaluate the clinical outcomes of integrating celiac plexus neurolysis (CPN) with standard first-line systemic therapy in patients diagnosed with advanced biliopancreatic malignancies and concomitant cancer-related pain.
Eligible participants are adults with histologically confirmed, inoperable advanced biliary tract cancer or pancreatic cancer, who present with moderate to severe abdominal pain and are candidates for first-line systemic treatment. All patients will be managed according to routine clinical practice; the decision to perform CPN and the choice of specific systemic therapy regimen will be determined by the treating physician team based on standard guidelines and individual patient circumstances, not by the study protocol.
The primary objective is to assess the efficacy of this integrated approach, with co-primary endpoints of pain response rate and objective tumor response rate. Pain response is defined as a reduction of ≥2 points in the Numeric Rating Scale score or a ≥50% decrease in opioid consumption sustained for ≥4 weeks. Tumor response will be evaluated per RECIST 1.1 criteria. Secondary objectives include comparing overall survival, progression-free survival, and quality of life metrics between the cohort receiving CPN combined with systemic therapy and a contemporary control cohort receiving systemic therapy alone. Safety will be assessed by monitoring the incidence and severity of adverse events related to both CPN and the systemic treatments.
Clinical data, including pain scores, analgesic usage, tumor imaging assessments, and laboratory results, will be prospectively collected at predefined time points for a follow-up period of up to 2 years. The study aims to provide real-world evidence on whether the early integration of interventional pain management with oncological treatment can improve overall patient outcomes in this population with high symptom burden.
- Being tested
- First-Line Systemic Therapy, Celiac Plexus Neurolysis (CPN)
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-Line Systemic TherapyDrug
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.
Celiac Plexus Neurolysis (CPN)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: First-Line Systemic Therapy; Procedure: Celiac Plexus Neurolysis (CPN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From the start of combination therapy until the first documented progression or death from any cause, assessed up to 2 years.
Overall Survival (OS)
The time from the start of combination therapy to death from any cause.
Measured: From the start of combination therapy until death from any cause, assessed up to 3 years.
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.
Measured: Baseline, and at 4, 8, and 12 weeks after the start of combination therapy.
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.
Measured: Baseline, and at 12 and 24 weeks after the start of combination therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start26 Dec 2025
- Primary completion26 Jun 2028 (estimated)
- Study completion26 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract Cancer(BTC)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326137
- Sponsor's protocol ID
- TJ-IRB202512171
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of First-Line Systemic Therapy Combined With Celiac Plexus Blockade in Patients With Advanced Biliopancreatic Malignancies and Cancer-Related Pain
- ClinicalTrials.gov ID
- NCT07326137
- Acronym / sponsor ID
- TJ-IRB202512171
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 26 Jun 2028 (estimated)
- Study completion
- 26 Dec 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational, single-center cohort study designed to evaluate the clinical outcomes of integrating celiac plexus neurolysis (CPN) with standard first-line systemic therapy in patients diagnosed with advanced biliopancreatic malignancies and concomitant cancer-related pain.
Eligible participants are adults with histologically confirmed, inoperable advanced biliary tract cancer or pancreatic cancer, who present with moderate to severe abdominal pain and are candidates for first-line systemic treatment. All patients will be managed according to routine clinical practice; the decision to perform CPN and the choice of specific systemic therapy regimen will be determined by the treating physician team based on standard guidelines and individual patient circumstances, not by the study protocol.
The primary objective is to assess the efficacy of this integrated approach, with co-primary endpoints of pain response rate and objective tumor response rate. Pain response is defined as a reduction of ≥2 points in the Numeric Rating Scale score or a ≥50% decrease in opioid consumption sustained for ≥4 weeks. Tumor response will be evaluated per RECIST 1.1 criteria. Secondary objectives include comparing overall survival, progression-free survival, and quality of life metrics between the cohort receiving CPN combined with systemic therapy and a contemporary control cohort receiving systemic therapy alone. Safety will be assessed by monitoring the incidence and severity of adverse events related to both CPN and the systemic treatments.
Clinical data, including pain scores, analgesic usage, tumor imaging assessments, and laboratory results, will be prospectively collected at predefined time points for a follow-up period of up to 2 years. The study aims to provide real-world evidence on whether the early integration of interventional pain management with oncological treatment can improve overall patient outcomes in this population with high symptom burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Biliary Tract Cancer Cohort | – | Drug: First-Line Systemic Therapy, Procedure: Celiac Plexus Neurolysis (CPN)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. |
| Advanced Pancreatic Cancer Cohort | – | Drug: First-Line Systemic Therapy, Procedure: Celiac Plexus Neurolysis (CPN)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First-Line Systemic TherapyStandard 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. | Drug | Advanced Biliary Tract Cancer Cohort, Advanced Pancreatic Cancer Cohort |
| 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. | Procedure or surgery | Advanced Biliary Tract Cancer Cohort, Advanced Pancreatic Cancer Cohort |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the start of combination therapy until the first documented disease progression or the end of follow-up, assessed up to 2 years.
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.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the start of combination therapy until the first documented progression or death from any cause, assessed up to 2 years.
Overall Survival (OS)
Time frame: From the start of combination therapy until death from any cause, assessed up to 3 years.
Change in Pain Intensity (Numerical Rating Scale, NRS)
Time frame: Baseline, and at 4, 8, and 12 weeks after the start of combination therapy.
Change in Quality of Life (QoL) Scores (EORTC QLQ-C30)
Time frame: Baseline, and at 12 and 24 weeks after the start of combination therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Biliary Tract Cancer(BTC) and Advanced Pancreatic Cancers, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Dr. Wu, M.D. (13636076910, 255001907@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From the start of combination therapy until the first documented disease progression or the end of follow-up, assessed up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.