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Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04931394
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Guo ShiWei, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Other: Adjuvant chemotherapy guided by organoid drug sensitivity test Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Organoid-Guided Adjuvant Chemotherapy
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.
Other: Adjuvant chemotherapy guided by organoid drug sensitivity test
Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.

No Intervention: Physician-decided Adjuvant Chemotherapy
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.



Primary Outcome Measures :
  1. Disease free time [ Time Frame: 1-2 years ]
    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 :
  1. Overall survival time [ Time Frame: 2-4 years ]
    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.

  2. 1-year disease-free survival [ Time Frame: 1 year ]
    The percentage of patients without recurrence by one year.

  3. The successful establishment rate of organoids [ Time Frame: 2-4 years ]
    The rate of organoid successfully cultured in all the samples collected.

  4. Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics). [ Time Frame: 2-4 years ]
    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.

  5. Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics). [ Time Frame: 2-4 years ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931394


Contacts
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Contact: Shiwei Guo, M.D. +8618621500666 gestwa@163.com
Contact: Huan Wang, Master +8617317492841 mr_wang_huan@163.com

Locations
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China
Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Shiwei Guo, M.D.    +8618621500666    gestwa@163.com   
Principal Investigator: Gang Jin, M.D.         
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Gang Jin, M.D. Changhai Hospital, Shanghai, China
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Responsible Party: Guo ShiWei, Associated Professor at the Institute of Pancreatic Surgery, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04931394    
Other Study ID Numbers: ChanghaiH-PP08
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guo ShiWei, Changhai Hospital:
Pancreatic Cancer
Organoid
Drug Sensitivity Test
Chemotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases