Pancreatic CancerPhase 3NCT04931394
Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
A Phase 3 study testing Adjuvant chemotherapy guided by organoid drug sensitivity test in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Adjuvant chemotherapy guided by organoid drug sensitivity test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Adjuvant chemotherapy guided by organoid drug sensitivity test
- Keywords
- Pancreatic Cancer, Organoid, Drug Sensitivity Test, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapy guided by organoid drug sensitivity testOther
Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 years
Secondary outcomes (5)
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.
Measured: 2-4 years
1-year disease-free survival
The percentage of patients without recurrence by one year.
Measured: 1 year
The successful establishment rate of organoids
The rate of organoid successfully cultured in all the samples collected.
Measured: 2-4 years
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.
Measured: 2-4 years
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.
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jun 2021
- Primary completion31 May 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo ShiWei, Changhai Hospital
- Investigators
- Gang Jin, M.D., Principal investigator, Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931394
- Sponsor's protocol ID
- ChanghaiH-PP08
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the published article (text, tables, figures, and appendix), together with a data dictionary defining each field in the dataset. The study protocol and the statistical analysis plan will also be available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test
- ClinicalTrials.gov ID
- NCT04931394
- Acronym / sponsor ID
- ChanghaiH-PP08
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Organoid, Drug Sensitivity Test, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organoid-Guided Adjuvant Chemotherapy | Experimental | Other: Adjuvant chemotherapy guided by organoid drug sensitivity testThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant chemotherapy guided by organoid drug sensitivity testAdjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients. | Other | Organoid-Guided Adjuvant Chemotherapy |
Primary outcome
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.
5 secondary outcomes
Overall survival time
Time frame: 2-4 years
1-year disease-free survival
Time frame: 1 year
The successful establishment rate of organoids
Time frame: 2-4 years
Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics).
Time frame: 2-4 years
Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics).
Time frame: 2-4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the published article (text, tables, figures, and appendix), together with a data dictionary defining each field in the dataset. The study protocol and the statistical analysis plan will also be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Jin, M.D. principal investigator
Changhai Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant chemotherapy guided by organoid drug sensitivity test in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free time (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.