Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients

NCT ID: NCT05634694

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-12-01

Brief 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.

Conditions

Cholangiocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions.

Intervention Type: OTHER

No interventions.

Interventions

No interventions.

No interventions.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Honghua Zhang, PhD

Role: CONTACT

zhanghh68@mail.sysu.edu.cn

020-34078840

Facility Contacts

Honghua Zhang, PhD

Role: primary

zhanghh68@mail.sysu.edu.cn

020-34078840

Other Identifiers

SYSKY-2022-168-01

Identifier Type: -

Identifier Source: org_study_id