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A trial for construction of organoids database and individual drug sensitivity test of patients with cholangiocarcinoma (intrahepatic and extrahepatic cholangiocarcinoma)

A trial for construction of organoids database and individual drug sensitivity test of patients with cholangiocarcinoma (intrahepatic and extrahepatic cholangiocarcinoma)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044579
Enrollment
Unknown
Registered
2021-03-24
Start date
2021-06-30
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholangiocarcinoma

Interventions

Group A:Treating with Gemcitabine and Cis-platinum
Group B:Treating with Oxaliplatin and Fluorouracil
Group C:Treating with Gemcitabine and Fluorouracil
Group D:Treating with Gemcitabine
Group E:Treating with Fluorouracil
Group F:Treating with Oxaliplatin

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-80 years; 2.Cholangiocarcinoma was diagnosed by preoperative pathological examinarion or clincal examinarion; 3.ECOG score between 0-2 points; 4.The expected survival time was more than 12 weeks 5.Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are suitable for radical surgery or have progressed R1 resection or palliative surgery; 6.Adequate hepatic, hematologic and renal functions(ALT= 3 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 80 x 10^9/L , hemoglobin >= 90g/L, creatinine clearance rate >= 60ml/min; 7.Volunteer for this study, have written informed consent.

Exclusion criteria

Exclusion criteria: 1. Have recieved following treatment before this study: (1) Anti-tumor chemotheropy or molecular target therapy as palliative treatment; (2) lesions have been treated by irradiation; (3) participate in other theraputic or interventional clinical trials; 2. Have central nervous system metastasis; 3. History of other malignancies except cholangiocarcinoma 4. Have symptomatic ascites and need for treatment; 5. Have serious concurrent illness including, but not limited to (1) uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(SBP>160mmHg or DBP>100mmHg); (2) ongoing or active serious infection; (3) uncontrolled diabetes mellitus; (4) HIV infection; (5) psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol; (6) other serious illness considered not suitable for this study by investigators.

Design outcomes

Primary

MeasureTime frame
The size and quantity of organoids;Half maximum inhibitory concentration (IC50);Progression free survival;Objective Response Rate;Clinical Benefit Response;

Countries

China

Contacts

Public ContactLiu Yingbin
laoniulyb@163.com+86 13918803900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026