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Trial Title:
Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients
NCT ID:
NCT05634694
Condition:
Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Hypersensitivity
Conditions: Keywords:
Cholangiocarcinoma
Chemotherapy
Adjuvant therapy
Patient-Derived Organoid
Drug Sensitivity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No interventions.
Description:
No interventions.
Arm group label:
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
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 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.
Criteria for eligibility:
Study pop:
Histologically confirmed cholangiocarcinoma patients who underwent radical resection and
received post-operation adjuvant chemotherapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. The patient must sign an informed consent form;
2. Age 18-75 years old, both male and female;
3. ECOG performance status score (PS score) 0-2;
4. Child-Pugh score A period;
5. Cholangiocarcinoma with negative margins confirmed by histopathology;
6. Have not received any systemic treatment within 6 months;
7. 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);
8. For women who are not breastfeeding or pregnant, use contraception during treatment
or 12 months after the end of treatment.
Exclusion Criteria:
1. Unresectable cholangiocarcinoma patients or postoperative diagnosis of
cholangiocarcinoma recurrence and metastasis;
2. Past or simultaneous suffering from other malignant tumors;
3. Have used gemcitabine-based chemotherapy or radiotherapy within 6 months;
4. Severe cardiopulmonary and renal dysfunction;
5. 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);
6. Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving
thrombolysis or anticoagulation therapy;
7. After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000;
8. A history of esophageal and gastric varices, significant clinically significant
bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
9. 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;
10. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
11. A history of psychotropic drug abuse, alcohol or drug abuse;
12. Known to have a history of severe allergies to any platinum drugs, or gemcitabine;
13. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510220
Country:
China
Status:
Recruiting
Contact:
Last name:
Honghua Zhang, PhD
Phone:
020-34078840
Email:
zhanghh68@mail.sysu.edu.cn
Start date:
November 30, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634694
