Back to resultsOrganoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Adjuvant chemotherapy guided by organoid drug sensitivity test
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Organoid, Drug Sensitivity Test, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Age≥18 years old and ≤80 years old.
- Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.
- Histology confirmed pancreatic adenocarcinoma.
- Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
- No metastases are found in preoperative examination.
- No prior chemotherapy or radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of greater than 90 days, as judged by the investigator.
- Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3.
- Normal liver function: serum total bilirubin≤2.0mg/dl, aminotransferase (ALT) and aspertate aminotransferase (AST) <2.5 times of the upper limit of normal value.
- Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min.
- The pancreatic cancer organoid were cultured successfully.
- No severe comorbidities.
Exclusion Criteria:
- Patients with poor condition can not tolerate chemotherapy and targeted therapy.
- Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
- Patients diagnosed with other cancer within 5 years.
- Patients who are pregnant or breastfeeding.
- Patients enrolled in other clinical trials or incompliant of regular follow up.
- Patients who did not provide an informed consent.
Sites / Locations
- Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Organoid-Guided Adjuvant Chemotherapy
Physician-decided Adjuvant Chemotherapy
Arm Description
The pancreatic cancer specimens are obtained from surgery to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan). Patients will receive relatively sensitive chemotherapy regimen based on the test results. Adjuvant chemotherapy should start within 2 months after surgery, and last at least 6 months.
The pancreatic cancer specimens are obtained from surgery to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan). Physician will decide the the adjuvant chemotherapy regimen, according to National Comprehensive Cancer Network (NCCN) guideline for pancreatic ductal adenocarcinoma. And they don't know the drug sensitivity test results. Adjuvant chemotherapy should start within 2 months after surgery, and last at least 6 months.
Outcomes
Primary Outcome Measures
Disease free time
Time from the date of randomization to recurrence based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier.
Secondary Outcome Measures
Overall survival time
The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for Overall survival (OS) analysis.
1-year disease-free survival
The percentage of patients without recurrence by one year.
The successful establishment rate of organoids
The rate of organoid successfully cultured in all the samples collected.
Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics).
To assess the accuracy of drug sensitivity test in both group.The number of patients with correct prediction of treatment response by organoid drug-sensitivity test divided by the number of patients underwent chemotherapy.
Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics).
To assess the accuracy of radiosensitivity test in both group. The number of patients with correct prediction of treatment response by organoid radiosensitivity test divided by the number of patients underwent radiotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04931394
Brief Title
Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
Official Title
A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to explore whether adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of pancreatic cancer. At the same time, this study will evaluate the successful establishment rate of organoid from fresh surgical specimens , and explore the concordance between drug sensitivity test results and patients' treatment response.
Detailed Description
The poor prognosis of pancreatic cancer is not just because of the high malignancy of the tumor itself, but also its poor response to chemotherapy. At present, patient's drug-sensitivity is assessed by progression time after treatment. Therefore, it is difficult to judge a patient's sensitivity to a drug before adjuvant chemotherapy. Organoid is a new tumor model, which has the potential to test the drug sensitivity before chemotherapy.
Our center's previous experience has shown that the success rate of pancreatic cancer organoid culture is 77.6%. The previous research has confirmed that pancreatic cancer organoid was highly consistent with the original tissue in terms of genomics and histomorphology. More importantly, the investigators have tested the five first-line drug-sensitivity in 39 pancreatic cancer organoids, and compared the test results with the clinical treatment response of these patients, confirming that organoid can accurately evaluate the chemotherapy drug-sensitivity.
This is a single-center, prospective, open-label, randomized, controlled clinical trial, designed to explore whether adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve outcomes in pancreatic cancer patients. At the same time, the consistency between the drug sensitivity test results and the treatment response of patients will be analyzed. Also, the radiosensitivity of organoid will be tested, and be compared with the patients' response to radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Organoid, Drug Sensitivity Test, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Organoid-Guided Adjuvant Chemotherapy
Arm Type
Experimental
Arm Description
The pancreatic cancer specimens are obtained from surgery to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan). Patients will receive relatively sensitive chemotherapy regimen based on the test results. Adjuvant chemotherapy should start within 2 months after surgery, and last at least 6 months.
Arm Title
Physician-decided Adjuvant Chemotherapy
Arm Type
No Intervention
Arm Description
The pancreatic cancer specimens are obtained from surgery to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan). Physician will decide the the adjuvant chemotherapy regimen, according to National Comprehensive Cancer Network (NCCN) guideline for pancreatic ductal adenocarcinoma. And they don't know the drug sensitivity test results. Adjuvant chemotherapy should start within 2 months after surgery, and last at least 6 months.
Intervention Type
Other
Intervention Name(s)
Adjuvant chemotherapy guided by organoid drug sensitivity test
Intervention Description
Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.
Primary Outcome Measure Information:
Title
Disease free time
Description
Time from the date of randomization to recurrence based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier.
Time Frame
1-2 years
Secondary Outcome Measure Information:
Title
Overall survival time
Description
The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for Overall survival (OS) analysis.
Time Frame
2-4 years
Title
1-year disease-free survival
Description
The percentage of patients without recurrence by one year.
Time Frame
1 year
Title
The successful establishment rate of organoids
Description
The rate of organoid successfully cultured in all the samples collected.
Time Frame
2-4 years
Title
Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics).
Description
To assess the accuracy of drug sensitivity test in both group.The number of patients with correct prediction of treatment response by organoid drug-sensitivity test divided by the number of patients underwent chemotherapy.
Time Frame
2-4 years
Title
Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics).
Description
To assess the accuracy of radiosensitivity test in both group. The number of patients with correct prediction of treatment response by organoid radiosensitivity test divided by the number of patients underwent radiotherapy.
Time Frame
2-4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥18 years old and ≤80 years old.
Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.
Histology confirmed pancreatic adenocarcinoma.
Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
No metastases are found in preoperative examination.
No prior chemotherapy or radiotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of greater than 90 days, as judged by the investigator.
Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3.
Normal liver function: serum total bilirubin≤2.0mg/dl, aminotransferase (ALT) and aspertate aminotransferase (AST) <2.5 times of the upper limit of normal value.
Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min.
The pancreatic cancer organoid were cultured successfully.
No severe comorbidities.
Exclusion Criteria:
Patients with poor condition can not tolerate chemotherapy and targeted therapy.
Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
Patients diagnosed with other cancer within 5 years.
Patients who are pregnant or breastfeeding.
Patients enrolled in other clinical trials or incompliant of regular follow up.
Patients who did not provide an informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiwei Guo, M.D.
Phone
+8618621500666
Email
gestwa@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huan Wang, Master
Phone
+8617317492841
Email
mr_wang_huan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Jin, M.D.
Organizational Affiliation
Changhai Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiwei Guo, M.D.
Phone
+8618621500666
Email
gestwa@163.com
First Name & Middle Initial & Last Name & Degree
Gang Jin, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
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