Pancreatic Ductal AdenocarcinomaHOPE-1NCT05611359
Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer
A study testing Thermal Ablation and Chemotherapy in people with Pancreatic Ductal Adenocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The goal of this clinical trial is to compare the overall survival of thermal ablation combined with chemotherapy and chemotherapy alone in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Thermal Ablation and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2026
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age ≥ 18; (2) pancreatic ductal adenocarcinoma was confirmed by pathology; (3) The patient's liver function was Child Pugh A or B ; (4) Karnofsky score ≥ 80; (5) There is a safe puncture path under the guidance of ultrasound for liver oligometastatic tumor; (6) Single diameter of liver oligometastatic tumor ≤ 5 cm, or ≤ 3 liver oligometastatic tumors, each diameter ≤ 3 cm; (7) Platelet count>40000/mm3; (8) Thrombin time ratio>40%; (9) Sign the Informed Consent of Clinical Trial.
Who cannot join
- (1) Refuse to receive chemotherapy or thermal ablation; (2) >3 liver metastases or extrahepatic metastases (such as peritoneum, lung, bone or brain); (3) Single diameter of liver oligometastatic tumor>5 cm; (4) The patient has ascites, portal vein thrombosis, or bile duct dilatation or stenosis; (5) Presence of another malignant tumors; (6) Prior anti-tumor treatment (including radiotherapy, chemotherapy and thermal ablation); (7) Presence of central nervous system abnormalities, mental diseases, unstable angina, congestive heart failure, serious arrhythmia or other serious diseases; (8) Use of anticoagulants maintenance treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Resection of the Primary Pancreatic Tumour and Thermal Hepatic Ablation Combined With Chemotherapy vs. Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer: A Randomized Controlled Trial
The goal of this clinical trial is to compare the overall survival of thermal ablation combined with chemotherapy and chemotherapy alone in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery.
The main question it aims to answer is: whether thermal ablation combined with chemotherapy can effectively prolong the overall survival in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery.
The participants in the treatment group will receive systemic chemotherapy combined with liver thermal ablation, while the participants in the control group will receive chemotherapy alone. All participants will be followed up to evaluate the overall survival after treatment.
Read the detailed description
How to improve the overall survival in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery is still a huge challenge in clinic. Chemotherapy is still the first-line treatment for patients with liver oligometastasis after PDAC resection. On the basis of chemotherapy, the clinical benefits of removing hepatic oligometastasis by thermal ablation are still unclear. In this study, we will recruit patients with liver oligometastasis after PDAC surgery to explore the effect of thermal ablation combined with chemotherapy on the overall survival of patients.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Thermal Ablation, Chemotherapy
- Keywords
- Pancreatic Ductal Adenocarcinoma, Hepatic Metastasis, Thermal Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal AblationProcedure or surgery
Also called Thermal Ablation Combined with Chemotherapy
Thermal hepatic ablation Combined with Chemotherapy
ChemotherapyDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Thermal Ablation | Experimental | In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, thermal ablation and chemotherapy are administered. Receives: Procedure: Thermal Ablation; Drug: Chemotherapy |
| Chemotherapy | Active comparator | In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from enrollment to death
Measured: 2 years
Secondary outcomes (6)
Progression-free survival time
Time from thermal ablation to recurrence of liver lesion
Measured: 2 years
Procedure related complications
Relevant complication after thermal ablation
Measured: up to 12 months
Procedure related mortality
Measured: up to 12 months
Patient satisfaction
Satisfaction questionnaire designed by investigator group
Measured: 2 years
Medical cost
Hospital expenditure
Measured: 2 years
Serum concentration of serological examinationof liver function
Serum concentration of tunmor biomarkers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study startJan 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- pintong huang, Doctor, Study chair, the 2th affiliated hospital of zhejiang university school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611359
- Sponsor's protocol ID
- 2022-0698
- Acronym
- HOPE-1
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No