Pancreatic Ductal Adenocarcinoma (PDAC)NCT07683845
Patient-Derived Organoid-on-a-Chip Model for Personalized Prediction of Chemotherapy Efficacy in Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Beijing Daxiang Biotech Co., Ltd at 1 site in China.
Trial summary
1. Background Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies worldwide, with a 5-year survival rate below 10%. Systemic chemotherapy is the mainstay of treatment for the majority of patients who present with unresectable disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2026to 20 Feb 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises treatment-naïve patients aged 18-75 years with histologically confirmed pancreatic ductal adenocarcinoma (PDAC) scheduled to receive first-line chemotherapy for borderline resectable, locally advanced, or metastatic disease. Eligible patients must have measurable disease per RECIST 1.1, ECOG performance status 0-2, life expectancy ≥3 months, and adequate organ function. Patients must provide sufficient fresh tumor tissue from surgery or biopsy (EUS-FNB 19G/22G) with tumor cell content and viability >50%. Approximately 164 patients will be screened to achieve 80 evaluable cases, accounting for follow-up rate of 90%, organoid culture success rate of 85%, and exclusions due to non-PDAC pathology or non-first-line treatment. All participants must sign informed consent and comply with follow-up.
Who may be able to join
- Age 18-75 years, both sexes
- Pathologically confirmed pancreatic ductal adenocarcinoma (PDAC) in treatment-naïve patients
- Ability to obtain sufficient fresh tumor tissue samples for organoid establishment through surgery or biopsy
- Planned to receive neoadjuvant therapy for borderline resectable disease, conversion therapy for locally advanced disease, or first-line therapy for metastatic disease, using single-agent or combination chemotherapy
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status 0-2
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- Life expectancy ≥3 months
- Adequate organ and bone marrow function: hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; total bilirubin ≤1.5×ULN (or ≤3×ULN with biliary obstruction); ALT/AST ≤2.5×ULN (or ≤5×ULN with biliary obstruction); serum creatinine ≤1.5×ULN or CrCl >60 mL/min
- Willing to sign informed consent, good compliance, and able to comply with follow-up
Who cannot join
- Sample quantity, quality, or preservation does not meet requirements
- Expected transport time >24 hours (including samples stored overnight before delivery)
- Organoid culture failure or testing quality control failure
- Inability to tolerate chemotherapy regimens
- Severe comorbidities, uncontrolled conditions, or active infections
- Pregnancy or breastfeeding
Show all 9Show fewer
- History of severe autoimmune diseases
- Any unstable condition that may compromise patient safety or compliance
- Deemed unsuitable for inclusion by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Jiabin Jin, MD, 0086-18917762352, jjb11501@rjh.com.cn
About this study
Official title: A Study on the Consistency Between Patient-Derived Pancreatic Cancer Organoid-on-a-Chip Drug Sensitivity Test Results and Clinical Chemotherapy Efficacy
- Background Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies worldwide, with a 5-year survival rate below 10%. Systemic chemotherapy is the mainstay of treatment for the majority of patients who present with unresectable disease. However, the objective response rates for standard first-line regimens, such as nab-paclitaxel plus gemcitabine (AG) and FOLFIRINOX, are only 15-30%. Currently, there are no validated predictive biomarkers to guide chemotherapy selection, leading to a trial-and-error approach that exposes patients to unnecessary toxicity and delays effective treatment. Patient-derived organoids (PDOs) are three-dimensional in vitro models that recapitulate the genetic, histological, and phenotypic features of their source tumors. PDOs have shown promise as a functional precision medicine platform for predicting individual patient responses to anticancer therapies. Several retrospective and prospective studies across various tumor types have demonstrated high sensitivity and specificity for PDO-based drug sensitivity testing in predicting clinical outcomes. However, prospective data specifically focused on pancreatic cancer remain limited.
- Study Objective The primary objective of this study is to evaluate the concordance between PDO-based drug sensitivity test results and clinical efficacy in PDAC patients receiving standard first-line chemotherapy. Secondary objectives include optimizing culture conditions and drug testing protocols for pancreatic cancer PDOs derived from surgical and biopsy specimens.
- Study Design This is a prospective, observational, multicenter cohort study. The study will enroll treatment-naïve patients aged 18-75 years with histologically confirmed PDAC who are scheduled to receive first-line chemotherapy. Fresh tumor tissue will be obtained from routine surgical resection or biopsy procedures. PDOs will be established from the collected specimens and subjected to in vitro drug sensitivity testing against the corresponding chemotherapy regimens. The testing results will be classified as "sensitive" or "insensitive" based on IC50 values and maximum inhibition rates. Clinical treatment decisions will be made by the treating physicians according to standard guidelines and multidisciplinary team recommendations, independent of the PDO test results. Patients will be followed up every three treatment cycles with imaging assessments (CT or MRI) and laboratory evaluations. Clinical efficacy will be assessed using RECIST v1.1 criteria after six cycles or at the time of early surgery in the neoadjuvant setting. The concordance between PDO test results and clinical outcomes will be analyzed by calculating sensitivity, specificity, and overall accuracy.
- Study Population Approximately 164 patients will be screened to achieve 80 evaluable cases, accounting for a PDO culture success rate of 85%, a follow-up rate of 90%, and exclusions due to non-PDAC pathology or non-first-line treatment regimens. Eligible patients must have adequate organ and bone marrow function, an ECOG performance status of 0-2, and a life expectancy of at least 3 months. Exclusion criteria include inadequate sample quality, PDO culture failure, pregnancy, severe comorbidities, and unstable medical conditions.
- Study Sites This multicenter study is being conducted at six tertiary medical centers in China: Ruijin Hospital (Shanghai, lead site), Peking University Cancer Hospital, Beijing Friendship Hospital, The Second Hospital of Tianjin Medical University, The Second Xiangya Hospital of Central South University, and Shenzhen People's Hospital.
- Risks and Benefits This observational study poses no additional physical risk to participants, as samples are collected from residual tissue during routine diagnostic or therapeutic procedures. No investigational interventions are administered. Participants will not receive direct medical benefit from study participation; however, the findings may contribute to the development of a clinically applicable predictive tool to guide chemotherapy selection for future pancreatic cancer patients, potentially improving treatment outcomes and quality of life.
- Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki and applicable Chinese regulations. The protocol has been reviewed and approved by the institutional ethics committee. Written informed consent will be obtained from all participants prior to enrollment. All data will be anonymized and handled in strict compliance with privacy protection regulations.
- Timeline The study is planned from February 2026 to February 2028.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- Pancreatic Ductal Adenocarcinoma, Patient-Derived Organoids, Drug Sensitivity Testing, Precision Medicine, Chemotherapy Response Prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer Patients Receiving First-Line Chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance Between Organoid Drug Sensitivity Test Results and Clinical Chemotherapy Efficacy in Pancreatic Ductal Adenocarcinoma Patients, Assessed by Sensitivity, Specificity, and Overall Accuracy
Concordance between organoid drug sensitivity test results and clinical chemotherapy efficacy in pancreatic ductal adenocarcinoma patients. Organoid sensitivity is determined by exposing patient-derived organoids to chemotherapy regimens across 5-7 concentrations, measuring cell viability via ATP content, generating concentration-inhibition curves, and deriving IC50 values, with results classified as "sensitive" or "insensitive." Clinical efficacy is assessed using RECIST v1.1 criteria after six treatment cycles, classifying outcomes as complete response, partial response, stable disease (with CA199 decrease or SDa) as effective, and stable disease (with CA199 increase or SDb) or progressive disease as ineffective. Concordance is calculated as sensitivity, specificity, and overall accuracy using a four-fold table with 95% confidence intervals. Unit of Measure: Percentage (%) - specifically, sensitivity (%), specificity (%), and overall accuracy (%).
Measured: At the end of Cycle 6 (each cycle is 28 days), or at pre-surgery imaging for neoadjuvant patients; if death occurs before first post-treatment imaging, classified as ineffective.
Secondary outcomes (3)
Objective Response Rate (ORR) in Organoid-Sensitive vs. Insensitive Groups
ORR is defined as the proportion of patients achieving best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria. ORR will be calculated separately for the organoid-sensitive group and the organoid-insensitive group, and compared against the overall population to derive the ORR improvement rate in the sensitive group.
Unit of Measure: Percentage (%) of patients.
Measured: Assessed at the end of Cycle 6 (each cycle is 28 days). For neoadjuvant patients, assessed at pre-surgery imaging. If death occurs before first post-treatment imaging, classified as non-responder.
Disease Control Rate (DCR) in Organoid-Sensitive vs. Insensitive Groups
DCR is defined as the proportion of patients achieving best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 criteria. DCR will be calculated separately for the organoid-sensitive group and the organoid-insensitive group.
Unit of Measure: Percentage (%) of patients.
Measured: Assessed at the end of Cycle 6 (each cycle is 28 days). For neoadjuvant patients, assessed at pre-surgery imaging. If death occurs before first post-treatment imaging, classified as non-responder.
Progression-Free Survival (PFS) in Organoid-Sensitive vs. Insensitive Groups
PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first. Patients alive without progression at the time of analysis will be censored at the last valid tumor assessment. PFS curves will be estimated using the Kaplan-Meier method, and PFS distribution will be compared between the organoid-sensitive and organoid-insensitive groups using the log-rank test.
Unit of Measure: Months (from treatment initiation to event).
Measured: Assessed every 3 treatment cycles (each cycle is 28 days) from treatment initiation until disease progression or death from any cause, with primary analysis time points at 6 months and 12 months post-treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start20 Feb 2026
- Primary completion20 Feb 2028 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Beijing Daxiang Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital, Beijing Friendship Hospital, Tianjin Medical University Second Hospital, Second Xiangya Hospital of Central South University, Shenzhen People's Hospital, Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683845
- Sponsor's protocol ID
- DX-PDAC-01
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Consistency Between Patient-Derived Pancreatic Cancer Organoid-on-a-Chip Drug Sensitivity Test Results and Clinical Chemotherapy Efficacy
- ClinicalTrials.gov ID
- NCT07683845
- Acronym / sponsor ID
- DX-PDAC-01
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- Pancreatic Ductal Adenocarcinoma, Patient-Derived Organoids, Drug Sensitivity Testing, Precision Medicine, Chemotherapy Response Prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Beijing Daxiang Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital, Beijing Friendship Hospital, Tianjin Medical University Second Hospital, Second Xiangya Hospital of Central South University, Shenzhen People's Hospital, Peking University Cancer Hospital & Institute
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Feb 2028 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 6 Jul 2026 (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.
- Background Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies worldwide, with a 5-year survival rate below 10%. Systemic chemotherapy is the mainstay of treatment for the majority of patients who present with unresectable disease. However, the objective response rates for standard first-line regimens, such as nab-paclitaxel plus gemcitabine (AG) and FOLFIRINOX, are only 15-30%. Currently, there are no validated predictive biomarkers to guide chemotherapy selection, leading to a trial-and-error approach that exposes patients to unnecessary toxicity and delays effective treatment. Patient-derived organoids (PDOs) are three-dimensional in vitro models that recapitulate the genetic, histological, and phenotypic features of their source tumors. PDOs have shown promise as a functional precision medicine platform for predicting individual patient responses to anticancer therapies. Several retrospective and prospective studies across various tumor types have demonstrated high sensitivity and specificity for PDO-based drug sensitivity testing in predicting clinical outcomes. However, prospective data specifically focused on pancreatic cancer remain limited.
- Study Objective The primary objective of this study is to evaluate the concordance between PDO-based drug sensitivity test results and clinical efficacy in PDAC patients receiving standard first-line chemotherapy. Secondary objectives include optimizing culture conditions and drug testing protocols for pancreatic cancer PDOs derived from surgical and biopsy specimens.
- Study Design This is a prospective, observational, multicenter cohort study. The study will enroll treatment-naïve patients aged 18-75 years with histologically confirmed PDAC who are scheduled to receive first-line chemotherapy. Fresh tumor tissue will be obtained from routine surgical resection or biopsy procedures. PDOs will be established from the collected specimens and subjected to in vitro drug sensitivity testing against the corresponding chemotherapy regimens. The testing results will be classified as "sensitive" or "insensitive" based on IC50 values and maximum inhibition rates. Clinical treatment decisions will be made by the treating physicians according to standard guidelines and multidisciplinary team recommendations, independent of the PDO test results. Patients will be followed up every three treatment cycles with imaging assessments (CT or MRI) and laboratory evaluations. Clinical efficacy will be assessed using RECIST v1.1 criteria after six cycles or at the time of early surgery in the neoadjuvant setting. The concordance between PDO test results and clinical outcomes will be analyzed by calculating sensitivity, specificity, and overall accuracy.
- Study Population Approximately 164 patients will be screened to achieve 80 evaluable cases, accounting for a PDO culture success rate of 85%, a follow-up rate of 90%, and exclusions due to non-PDAC pathology or non-first-line treatment regimens. Eligible patients must have adequate organ and bone marrow function, an ECOG performance status of 0-2, and a life expectancy of at least 3 months. Exclusion criteria include inadequate sample quality, PDO culture failure, pregnancy, severe comorbidities, and unstable medical conditions.
- Study Sites This multicenter study is being conducted at six tertiary medical centers in China: Ruijin Hospital (Shanghai, lead site), Peking University Cancer Hospital, Beijing Friendship Hospital, The Second Hospital of Tianjin Medical University, The Second Xiangya Hospital of Central South University, and Shenzhen People's Hospital.
- Risks and Benefits This observational study poses no additional physical risk to participants, as samples are collected from residual tissue during routine diagnostic or therapeutic procedures. No investigational interventions are administered. Participants will not receive direct medical benefit from study participation; however, the findings may contribute to the development of a clinically applicable predictive tool to guide chemotherapy selection for future pancreatic cancer patients, potentially improving treatment outcomes and quality of life.
- Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki and applicable Chinese regulations. The protocol has been reviewed and approved by the institutional ethics committee. Written informed consent will be obtained from all participants prior to enrollment. All data will be anonymized and handled in strict compliance with privacy protection regulations.
- Timeline The study is planned from February 2026 to February 2028.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer Patients Receiving First-Line Chemotherapy | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises treatment-naïve patients aged 18-75 years with histologically confirmed pancreatic ductal adenocarcinoma (PDAC) scheduled to receive first-line chemotherapy for borderline resectable, locally advanced, or metastatic disease. Eligible patients must have measurable disease per RECIST 1.1, ECOG performance status 0-2, life expectancy ≥3 months, and adequate organ function. Patients must provide sufficient fresh tumor tissue from surgery or biopsy (EUS-FNB 19G/22G) with tumor cell content and viability >50%. Approximately 164 patients will be screened to achieve 80 evaluable cases, accounting for follow-up rate of 90%, organoid culture success rate of 85%, and exclusions due to non-PDAC pathology or non-first-line treatment. All participants must sign informed consent and comply with follow-up.
Key inclusion criteria (9 listed)
- Age 18-75 years, both sexes
- Pathologically confirmed pancreatic ductal adenocarcinoma (PDAC) in treatment-naïve patients
- Ability to obtain sufficient fresh tumor tissue samples for organoid establishment through surgery or biopsy
- Planned to receive neoadjuvant therapy for borderline resectable disease, conversion therapy for locally advanced disease, or first-line therapy for metastatic disease, using single-agent or combination chemotherapy
- At least one measurable lesion per RECIST 1.1 criteria
Key exclusion criteria (9 listed)
- Sample quantity, quality, or preservation does not meet requirements
- Expected transport time >24 hours (including samples stored overnight before delivery)
- Organoid culture failure or testing quality control failure
- Inability to tolerate chemotherapy regimens
- Severe comorbidities, uncontrolled conditions, or active infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance Between Organoid Drug Sensitivity Test Results and Clinical Chemotherapy Efficacy in Pancreatic Ductal Adenocarcinoma Patients, Assessed by Sensitivity, Specificity, and Overall Accuracy
Time frame: At the end of Cycle 6 (each cycle is 28 days), or at pre-surgery imaging for neoadjuvant patients; if death occurs before first post-treatment imaging, classified as ineffective.
Concordance between organoid drug sensitivity test results and clinical chemotherapy efficacy in pancreatic ductal adenocarcinoma patients. Organoid sensitivity is determined by exposing patient-derived organoids to chemotherapy regimens across 5-7 concentrations, measuring cell viability via ATP content, generating concentration-inhibition curves, and deriving IC50 values, with results classified as "sensitive" or "insensitive." Clinical efficacy is assessed using RECIST v1.1 criteria after six treatment cycles, classifying outcomes as complete response, partial response, stable disease (with CA199 decrease or SDa) as effective, and stable disease (with CA199 increase or SDb) or progressive disease as ineffective. Concordance is calculated as sensitivity, specificity, and overall accuracy using a four-fold table with 95% confidence intervals. Unit of Measure: Percentage (%) - specifically, sensitivity (%), specificity (%), and overall accuracy (%).
3 secondary outcomes
Objective Response Rate (ORR) in Organoid-Sensitive vs. Insensitive Groups
Time frame: Assessed at the end of Cycle 6 (each cycle is 28 days). For neoadjuvant patients, assessed at pre-surgery imaging. If death occurs before first post-treatment imaging, classified as non-responder.
Disease Control Rate (DCR) in Organoid-Sensitive vs. Insensitive Groups
Time frame: Assessed at the end of Cycle 6 (each cycle is 28 days). For neoadjuvant patients, assessed at pre-surgery imaging. If death occurs before first post-treatment imaging, classified as non-responder.
Progression-Free Survival (PFS) in Organoid-Sensitive vs. Insensitive Groups
Time frame: Assessed every 3 treatment cycles (each cycle is 28 days) from treatment initiation until disease progression or death from any cause, with primary analysis time points at 6 months and 12 months post-treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Beijing Daxiang Biotech Co., Ltd 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Jul 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiabin Jin, MD (0086-18917762352, jjb11501@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance Between Organoid Drug Sensitivity Test Results and Clinical Chemotherapy Efficacy in Pancreatic Ductal Adenocarcinoma Patients, Assessed by Sensitivity, Specificity, and Overall Accuracy (time frame: At the end of Cycle 6 (each cycle is 28 days), or at pre-surgery imaging for neoadjuvant patients; if death occurs before first post-treatment imaging, classified as ineffective.). 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 6 Jul 2026.