Combining irinotecan liposome injection with chemotherapy and immunotherapy for advanced biliary tract cancer
Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer
This study is testing a new treatment that combines a special type of chemotherapy with immunotherapy to see if it can help people with advanced biliary tract cancer who haven't improved with previous treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06282120 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of irinotecan liposome injection combined with 5-FU and leucovorin, with or without immunotherapy, in patients with metastatic biliary tract cancer who have progressed after receiving gemcitabine and immunotherapy. The study aims to provide better treatment options for patients who have not responded to first-line therapies. Participants will be monitored for both the effectiveness of the treatment regimen and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed metastatic cholangiocarcinoma who have experienced disease progression after gemcitabine and immunotherapy.
Not a fit: Patients with non-metastatic disease or those who have not previously received gemcitabine and immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new second-line therapy option for patients with advanced biliary tract cancer.
How similar studies have performed: While this approach is being explored, the specific combination of irinotecan liposome injection with 5-FU/LV and immunotherapy in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. The patient had good compliance, could understand the research process of the study, and signed a written informed consent;
2. Age ≥18 years, ≤75 years;
3. Histologically or cytologically confirmed cholangiocarcinoma;
4. Documented metastatic disease;
5. At least one measurable lesion according to RECIST v1.1;
6. Disease progression after gemcitabine + immunotherapy;
7. For patients whose disease recurred after curative resection (R0 or R1), previous adjuvant 5-FU-based chemotherapy is allowed if there is at least 6 month-interval between the last dose of adjuvant chemotherapy and recurrence of disease;
8. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;
9. The expected survival time is greater than 3 months;
10. Having adequate organ function, as defined below:
1. Absolute neutrophil count (ANC) ≥1.5\*109/L
2. Hemoglobin ≥90g/dL
3. Platelets (PLT) ≥100\*109/L
4. Total bilirubin \< 1.5 times Upper Normal Value (ULN)
5. Chemical examination of liver function index (AST\&ALT) \< 2.5 times Upper Limit of Normal (ULN)
6. Serum creatinine (Cr) ≤1.5×ULN
11. Non-pregnant or lactating women; Effective contraception should be used by women/men of childbearing age during the study period and for 6 months after the end of study treatment-
Exclusion Criteria:
（1) Serum total bilirubin ≥2 x ULN (upper limit of normal) (biliary obstruction allows biliary drainage); （2）Severe renal impairment (Clcr ≤ 30 ml/min); （3）Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment； （4）Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 2; （5）Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months; （6） NYHA(New York Heart Association) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings; （7） Active infection or an unexplained fever \>38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's health; （8） Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors； （9） Known hypersensitivity to any of the components of Onivyde other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin; （10）Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use an effective method of contraception, during therapy and for 3 months following the last dose of Onivyde. Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index \< 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 3 months after last application of program treatment. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs; （11） Previous treatment with combination drug tegafur, gimeracil, and oteracil potassium with seven days before enrollment; （12） Current treatment with Sorivudine; （13） Severe fatigue or bone marrow depression after prior radiotherapy or antineoplastic therapy; （14）There are serious concomitant diseases, such as diabetes mellitus and can not be well controlled by hypoglycemic drugs, clinically serious (that is, active) heart disease, renal failure, liver failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, etc.; （15） History of other malignancy with a disease-free interval \<5 years (Registration is permitted if it has minimal impact on prognosis, such as carcinoma in situ and papillary thyroid cancer); （16） History or current eveidence of brain metastasis; （17）Patients deemed unsuitable for this trial by the investigator.
Where this trial is running
Tianjin, Tianjin
- Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.