Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer

NCT04931394 | Unknown Phase 3 DMC

• 1 other identifier: ChanghaiH-PP08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Organoid; Drug Sensitivity Test; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  1-2 years

Secondary Outcomes (5)

• Overall survival time

  2-4 years

• 1-year disease-free survival

  1 year

• The successful establishment rate of organoids

  2-4 years

• Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics).

  2-4 years

• Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics).

  2-4 years

Study Arms (2)

Organoid-Guided Adjuvant Chemotherapy

EXPERIMENTAL

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

Physician-decided Adjuvant Chemotherapy

NO INTERVENTION

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.

Interventions

Adjuvant chemotherapy guided by organoid drug sensitivity test OTHER

Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.

Organoid-Guided Adjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Gang Jin, M.D.

  Changhai Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwei Guo, M.D.

CONTACT

+8618621500666; gestwa@163.com

Huan Wang, Master

CONTACT

+8617317492841; mr_wang_huan@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor at the Institute of Pancreatic Surgery

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 18, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)