Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    200
  • sponsor
    Changhai Hospital
Updated on 29 June 2021
carcinoma
neutrophil count
pancreatic adenocarcinoma
cancer chemotherapy
adenocarcinoma

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.

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.

Details
Condition Pancreatic disorder, Pancreatic Cancer, cancer of the pancreas, Islet Ce417ll Cancer, Pancreatic Disorders, pancreatic cancers, Neoplasm of unspecified nature of digestive system, cancer, pancreatic, Digestive System Neoplasms
Treatment Adjuvant chemotherapy guided by organoid drug sensitivity test
Clinical Study IdentifierNCT04931394
SponsorChanghai Hospital
Last Modified on29 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age18 years old and 80 years old
Histology confirmed pancreatic adenocarcinoma
Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases
Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma
No prior chemotherapy or radiotherapy
No metastases are found in preoperative examination
Life expectancy of greater than 90 days, as judged by the investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3
Normal liver function: serum total bilirubin2.0mg/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
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