CholangiocarcinomaNCT05634694
Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients
An observational study of Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the consistency and accuracy of patient-derived organoid model of cholangiocarcinoma to predict the clinical chemotherapeutic efficacy, as well as the possibility of guiding the adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 1 Dec 2024
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed cholangiocarcinoma patients who underwent radical resection and received post-operation adjuvant chemotherapy.
Who may be able to join
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Child-Pugh score A period;
- Cholangiocarcinoma with negative margins confirmed by histopathology;
- Have not received any systemic treatment within 6 months;
- The functional indicators of important organs meet the following requirements (1)Neutrophils≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (calculated by Cockcroft-Gault formula);
- For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.
Who cannot join
- Unresectable cholangiocarcinoma patients or postoperative diagnosis of cholangiocarcinoma recurrence and metastasis;
- Past or simultaneous suffering from other malignant tumors;
- Have used gemcitabine-based chemotherapy or radiotherapy within 6 months;
- Severe cardiopulmonary and renal dysfunction;
- Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
- Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
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- After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000;
- A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
- Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;
- Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
- A history of psychotropic drug abuse, alcohol or drug abuse;
- Known to have a history of severe allergies to any platinum drugs, or gemcitabine;
- Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510220
Honghua Zhang, PhD, 020-34078840, zhanghh68@mail.sysu.edu.cn
About this study
Official title: Clinical Study on the Drug Sensitivity Consistency of Patient-Derived Organoid Model and Actual Therapeutic Efficacies in Cholangiocarcinoma Patients Receiving Adjuvant Chemotherapy After Radical Resection
This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the consistency and accuracy of patient-derived organoid model of cholangiocarcinoma to predict the clinical chemotherapeutic efficacy, as well as the possibility of guiding the adjuvant chemotherapy.
Read the detailed description
The chemotherapeutic efficacy is heterogeneous among cholangiocarcinoma patients after radical resection, and an accurate and relatively convenient model evaluating the chemotherapeutic efficacy is still lacking. This study aims to prospectively evaluate the consistency of drug sensitivity between patient-derived organoid model and the actual clinical chemotherapeutic efficacy in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.
Drug sensitivity tests include single drug and drug combination. The organoids that are successfully cultured will be kept in liquid nitrogen for a specific time.
- Conditions
- Cholangiocarcinoma
- Being tested
- No interventions.
- Keywords
- Cholangiocarcinoma, Chemotherapy, Adjuvant therapy, Patient-Derived Organoid, Drug Sensitivity
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions.Other
No interventions.
| Study group | Role | What they receive |
|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort. Receives: Other: No interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival status of cholangiocarcinoma patients after radical resection
The cholangiocarcinoma patients after radical resection are regularly followed-up for the progression-free survival status.
Measured: 12 months
Drug sensitivity of patient-derived tumor organoids
The drug sensitivity is tested on patient-derived tumor organoids, which is evaluated using Promega CellTiter-Glo 3D Cell Viability Assay to calculate the relative IC50, and is compared with the actual chemotherapeutic efficacy of cholangiocarcinoma patients.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start30 Nov 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Liu, PhD, Principal investigator, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634694
- Sponsor's protocol ID
- SYSKY-2022-168-01
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Drug Sensitivity Consistency of Patient-Derived Organoid Model and Actual Therapeutic Efficacies in Cholangiocarcinoma Patients Receiving Adjuvant Chemotherapy After Radical Resection
- ClinicalTrials.gov ID
- NCT05634694
- Acronym / sponsor ID
- SYSKY-2022-168-01
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, Chemotherapy, Adjuvant therapy, Patient-Derived Organoid, Drug Sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Dec 2022 (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.
This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the consistency and accuracy of patient-derived organoid model of cholangiocarcinoma to predict the clinical chemotherapeutic efficacy, as well as the possibility of guiding the adjuvant chemotherapy.
Detailed description
The chemotherapeutic efficacy is heterogeneous among cholangiocarcinoma patients after radical resection, and an accurate and relatively convenient model evaluating the chemotherapeutic efficacy is still lacking. This study aims to prospectively evaluate the consistency of drug sensitivity between patient-derived organoid model and the actual clinical chemotherapeutic efficacy in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.
Drug sensitivity tests include single drug and drug combination. The organoids that are successfully cultured will be kept in liquid nitrogen for a specific time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | – | Other: No interventions.The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed cholangiocarcinoma patients who underwent radical resection and received post-operation adjuvant chemotherapy.
Key inclusion criteria (8 listed)
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Child-Pugh score A period;
- Cholangiocarcinoma with negative margins confirmed by histopathology;
Key exclusion criteria (13 listed)
- Unresectable cholangiocarcinoma patients or postoperative diagnosis of cholangiocarcinoma recurrence and metastasis;
- Past or simultaneous suffering from other malignant tumors;
- Have used gemcitabine-based chemotherapy or radiotherapy within 6 months;
- Severe cardiopulmonary and renal dysfunction;
- Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
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 |
|---|---|---|
| No interventions.No interventions. | Other | Sun Yat-Sen Memorial Hospital of Sun Yat-sen University |
Primary outcome
Progression-free survival status of cholangiocarcinoma patients after radical resection
Time frame: 12 months
The cholangiocarcinoma patients after radical resection are regularly followed-up for the progression-free survival status.
Drug sensitivity of patient-derived tumor organoids
Time frame: 2 months
The drug sensitivity is tested on patient-derived tumor organoids, which is evaluated using Promega CellTiter-Glo 3D Cell Viability Assay to calculate the relative IC50, and is compared with the actual chemotherapeutic efficacy of cholangiocarcinoma patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- 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. This study is not recruiting at the moment.
Chao Liu, PhD principal investigator
Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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 Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honghua Zhang, PhD (020-34078840, zhanghh68@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival status of cholangiocarcinoma patients after radical resection (time frame: 12 months). The study lists 2 primary outcomes in all. 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 2 Dec 2022.